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Monoclonal Proteins by Blood Spot and Saliva
Rochester, MN
The purpose of this study is to assess the feasibility and develop procedures for detecting monoclonal proteins via finger pick blood spots and saliva. Data will be compared to results of serum data collected for patient care during the same time. The test will be evaluated qualitatively against venipunctured data tested by Mass Fix.
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Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
Rochester, MN
This pilot clinical trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.
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A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
Rochester, MN
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
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Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
Jacksonville, FL
The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.
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Trial of Sequential Treatment of Multiple Myeloma with Antibody Therapy
Jacksonville, FL
The purpose of this study is to determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with multiple myeloma resistant to daratumumab.
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Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa)
Rochester, MN
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
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A Study to Evaluate Myeloma-Developing Regimens Using Genomics (MyDRUG)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of ...
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A Study of MicroRNAs in Patients with Multiple Myeloma Treaded with Immunomodulatory Drugs
Scottsdale/Phoenix, AZ
The purpose of this study is to explore how IMiD treatments affect certain genetic material called (microRNAs) in the body of patients with multiple myeloma.
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A Study to Compare Subcutaneous Daratumumab with Intravenous Daratumumab
Rochester, MN
The purpose of this study is to evaluate qualtiy of life (QOL) metrics while receiving subcutaneous (SQ) daratumumab, patient satisfaction, and patient preference for IV and/or SC therapies.
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Cyclophosphamide, Ixazomib, and Dexamethasone in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and the best dose of cyclophosphamide when given together with ixazomib and dexamethasone in treating patients with previously untreated symptomatic multiple myeloma. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib and dexamethasone may be an effective treatment for multiple myeloma.
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Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant
Rochester, MN; Jacksonville, FL
This phase II trial studies how well pembrolizumab, lenalidomide, and dexamethasone work in treating patients with newly diagnosed multiple myeloma that are eligible for stem cell transplant. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab, lenalidomide, and dexamethasone may work better in treating patients with multiple myeloma.
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A Study of AO-176 as Monotherapy Combinated with Bortezomib and Dexamethasone in Adults with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of AO-176, including dose-limiting toxicities (DLT), maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) when administered as monotherapy, and in combination with dexamethasone (AO-176+DEX) in adult patients with Relapsed/Refractory Multiple Myleoma (R/R MM).
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Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
Rochester, MN
The purpose of this study is to find the maximum tolerated dose of iberdomide for patients newly diagnosed with multiple myeloma, and to determine response rate during induction treatment when combined with daratumumab, bortezomib and dexamethansone.
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Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
Jacksonville, FL
The current proposal aims to test the feasibility of immune function analysis for Tai Chi Easy (TCE) intervention in multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT) with concurrent exploration of health related quality of life (HRQOL).
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IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.
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SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
Scottsdale/Phoenix, AZ
Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). ...
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A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Jacksonville, FL
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
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A Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B.
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A Study Evaluating the Safety and Effectiveness of UCART Targeting CS1 in Patients with Relapsed/Refractory Multiple Myeloma (MELANI-01)
Rochester, MN
The purpose of this study is to evaluate the safety and clinical activity of one infusion of UCARTCS1A (t-cells) and to determine the Maximum Tolerated Dose (MTD).
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Testing the Addition of Ixazomib to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial
Rochester, MN
This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.
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A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).
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A Study to Evaluate the Safety and Effectiveness of Idecabtagene Vicleucel to Treat Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information.
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Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma
Rochester, MN
This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma (RRMM)).
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Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Rochester, MN
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.
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A Study to Determine Recommended Dose, Regimen and Evaluate the Safety and Preliminary Effectiveness of CC-92480 in Combination With Standard Treatments in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary effectiveness of CC-92480 in combination with standard treatments.
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Safety and Efficacy of ALLO-715 and ALLO-647 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Rochester, MN
The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.
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A Study to Compare Dual-Energy CT and Whole Body MRI for Monitoring of Bone Involvement in Multiple Myeloma Patients
Rochester, MN
The purpose of this study is to determine the performance of Dual-Energy CT (DECT) with Virtual Non-calcium (VNCa) and fat measurement in assessing multiple myeloma disease activity following treatment, with MRI and clinical/ laboratory parameters as reference standards.
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Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to estimate the rate of sustained MRD negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma.
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Lenalidomide or Observation in Treating Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
Rochester, MN
This phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk smoldering multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient.
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S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
Jacksonville, FL; Rochester, MN
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer ...
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Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients with Relapsed or Relapsed/Refractory Multiple Myeloma
Rochester, MN
This phase I/II trial studies the side effects and best dose of ixazomib and to see how well it works when given together with pomalidomide and dexamethasone in treating patients with relapsed or relapsed/refractory multiple myeloma. Ixazomib may stop the growth of cancer by interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide and dexamethasone can modify and regulate the immune system and may stop cancer cells from growing. Giving ixazomib with pomalidomide and dexamethasone may be an effective treatment for relapsed or relapsed/refractory multiple myeloma.
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Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
Rochester, MN
The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndrome (MDS).
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Belantamab, Lenalidomide, and Daratumumab for Newly-diagnosed Multiple Myeloma
Rochester, MN
The purpose of the phase 1 portion of this research study is to find out more about the side effects of belantamab and what doses of belantamab are safe for people when combined with lenalidomide and daratumumab, and to find the right dose for the phase 2 portion of the trial.
This trial is exploring the use of a new drug called belantamab to be used in combination with daratumumab and lenalidomide and not using the same doses of dexamethasone as has been done with previous combinations. Belantamab is an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate. This ...
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A Study to Evaluate TAK-981 Given With Monoclonal Antibodies In Adults With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to evaluate the safety and effectiveness of TAK-981 in combination with anti-CD38 monoclonal antibodies. TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies to treat participants who have relapsed or refractory multiple myeloma.
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Open-label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T-cells (CT053) in Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.
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A Study to Evaluate the Safety and Effectiveness of CAEL-101 and Plasma Cell Dyscrasia Treatment vs. Placebo and Plasma Cell Dyscrasia Tretment to Treat Patients with Mayo Stage IIIb AL Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if CAEL-101 and treatment for plasma cell dyscrasia improves overall survival in Mayo stage IIIb AL amyloidosis patients who are treatment naïve compared to treatment for plasma cell dyscrasia alone, and to evaluate the safety and tolerability of CAEL-101 in combination with treatment for plasma cell dyscrasia.
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A Study Comparing CAR-T Therapy Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants with Relapsed and Lenalidomide-Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
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Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Rochester, MN
This phase II trial studies how well lenalidomide and dexamethasone work in treating patients with relapsed or refractory multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells.
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Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
Scottsdale/Phoenix, AZ; Rochester, MN
Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: - To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. - To compare the Overall Survival (OS) between the two arms. - To evaluate the Time To Progression (TTP) in each arm. - To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in each arm. ...
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Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)
Rochester, MN
The purpose of this study is to compare the effectiveness (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
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A Study of Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients with Previously Treated Multiple Myeloma or Plasma Cell Leukemia
Rochester, MN
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
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A Study to Evaluate EAA181 to Treat Newly-diagnosed Multiple Myeloma
La Crosse, WI; Rochester, MN
The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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A Study to Evaluate the Effectiveness and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects with Clinical High-Risk Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effectiveness and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1) and in subjects with HR MM having progressed within one year of initial treatment (Cohort 2). Approximately 122 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2 will enroll approximately 49 MM subjects with 1 prior anti-myeloma treatment regimen and HR disease defined as Stage III by the Revised International Staging System (R-ISS) and early relapse. The cohorts will start in ...
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Dinaciclib, Bortezomib, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when given together with dexamethasone in treating patients with relapsed multiple myeloma. Dinaciclib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer cells.
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Ph 1b Study to Evaluate GSK2110183 in Combination with Bortezomib and Dexamethasone in Subjects with Multiple Myeloma
Scottsdale/Phoenix, AZ
Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety, tolerability and clinical activity of the MTD(s) identified in Part 1, including a pharmacokinetic cohort.
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Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma
Rochester, MN
This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with ...
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A Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW)
No Locations
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
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A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
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Study Evaluating the Safety and Effectiveness of JCARH125 in Subjects with Relapsed and/or Refractory Multiple Myeloma (EVOLVE)
Rochester, MN
The purpose of this study is to determine the safety and effectiveness of JCARH125 in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.
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A Study of JNJ-68284528, a Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants with Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the study is to characterize the safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the effectiveness of JNJ-68284528 (Phase 2).
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Alternate Doses and Dosing Schedules of Belantamab Mafodotin for the Treatment of Triple-Class Recurrent and/or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this study is to assess the 24-week grade 3/4 keratopathy-free rate of an alternative dose/dosing schedule for belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (RRMM).
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A Study to Determine the Effect of Distance Reiki on Patient Reported Quality of Life (PRQoL) and Immunity Among Multiple Myeloma Patients
Rochester, MN
This study aims to demonstrate acceptability and feasibility of the use of Distance Reiki therapy versus sham Reiki therapy among multiple myeloma patients.It also aims to determine if there is a minimal clinically meaningful improvement in various QOL domains (Physical, Social, Emotional), overall QOL with use of Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Single Item Linear Analogue Scale (LASA) after Distance Reik. Lastly, it aims to analyze the effect of Distance Reiki on expansion of the immune repertoire by comparing immune repertoires at baseline and at the end of the study by using Mass spectrometry by CyTOF® and multiplex ...
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Study to Evaluate Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The primary goal of this study is to determine response rates (>=PR) of prospectively treated MM patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
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A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and effectiveness of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every ...
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A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients with Mayo Stage IIIa AL Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if CAEL-101 improves the overall survival in patients with cardiac AL Amyloidosis.
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A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
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Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma
Jacksonville, FL; Rochester, MN
This phase I/II trial studies the side effects and best dose of carfilzomib when given together with melphalan and to see how well they work in treating patients with multiple myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill more cancer cells.
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An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are double refractory to a PI and an IMiD.
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SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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A Study to Evaluate ION251 to Treat Patients with Relapsed/Refractory Multiple Myleoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.
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A study of how current treatments impact the course of relapsed myeloma and the effect of the treatments on the quality-of-life measurements.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine the impact of standard of care therapies for TCR MM, in a real-world setting, on patient-reported symptoms, functioning, and QoL, measured prospectively using questionnaires. The secondary goal is to asses clinical endopoints associated with standard of care therapies for TCR MM, in a real-world setting during 12 months of observation.
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Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells
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Study of bb21217 in Multiple Myeloma
Rochester, MN
Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).
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Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma
Rochester, MN
The purpose of this research study is to evaluate a treatment regimen called IRD which will be given to participants after their stem cell transplant in an effort to help prolong the amount of time the participants are disease-free after transplant. IRD is a three-drug regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After 4 cycles of IRD, the participants will be randomized to receive maintenance therapy either with ixazomib or lenalidomide. 09/23/2019: Upon review of the interim analysis that suggested inferior progression-free survival in the ixazomib maintenance arm, there will be no further randomizations into the ...
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A Study to Evaluate APG2575 Combined with Novel Therapeutic Regimens To Treat Subjects with Relapsed or Refractory Multiple Myeloma and Immunoglobulin Light Chain Amyloidosis
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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The Impact of a Geriatric Assessment in Elderly Patients with Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (≥ 65 years) with multiple myeloma (MM).
Multiple myeloma (MM) is a blood cancer that affects a type of white cell called plasma cell. It mainly affects older individuals and has an average age at diagnosis of 69 years.
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A Study to Evaluate Daratumumab in Treating Transplant-Eligible Participants with Multiple Myeloma
Jacksonville, FL
To determine the percentage of patients achieving MRD negativity by MPF after autologous stem cell transplant (SCT) (at Day 100) using pre-SCT daratumumab consolidation.
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A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Impaired Renal Function
Jacksonville, FL
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.
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Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
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Appointment Companion Tool
Rochester, MN
The purpose of this study is to pilot the patient appointment companion (PAC) tool in use with patients with amyloidosis and multiple myeloma (MM). Patients with hematologic malignancies have unique information and communication needs compared to those with solid tumors. The internet has shifted the dynamics of the patient–doctor relationship, toward one of more mutual participation whereby power and responsibility are shared. The PAC was designed as a patient-centered, user-friendly platform that aids patients’ preparation for their visits with clinicians. PAC provides an online tool that empowers patients to direct their treatment preferences and care alongside their physician teams per the provisions ...
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A Study of JNJ‐68284528 Out‐of‐Specification (OOS) for Commercial Release in Patients with Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the effectiveness of cilta-cel OOS based on overall response of partial response (PR) or better (overall response rate, ORR) to treat multiple myeloma.
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S1211, Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
Jacksonville, FL; Rochester, MN
RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as lenalidomide and dexamethasone also work in different ways to kill tumor cells or stop them from growing. Giving elotuzumab together ...
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Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...
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Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
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Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the safety and effectiveness of bb2121 (Ide-Cel) combinations in subjects with relapsed/refractory multiple myeloma. It also aims to evaluate different agents and their doses/schedules to improve clinical effectiveness in combination with bb2121.
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A Study to Evaluate Lenalidomide and Dexamethasone, with or without Daratumumab, in Treating High-Risk Smoldering Myeloma Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...
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A Study of Atezolizumab Alone or Combined with Immunomodulatory Drug and/or Daratumumab in Multiple Myeloma Patients
Jacksonville, FL
This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.
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A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.
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Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relaped/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate HPN217 as monotherapy to assess the safety, tolerability and pharmacokinetics in patients with relapsed/ refractory multiple myeloma.
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Erismodegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma
Rochester, MN
This phase II trial studies how well erismodegib and lenalidomide after stem cell transplant works in treating patients with multiple myeloma. Erismodegib and lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay the recurrence of myeloma after a stem cell transplant.
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Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone ...
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A Study to Evaluate Tadalafil and Lenalidomide with or without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Jacksonville, FL
This research is being done to find out if altering the immune system by giving Prevnar vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
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Selinexor, Carfilzomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
This phase I trial studies the side effects and best dose of selinexor and carfilzomib when given together with dexamethasone in treating patients with multiple myeloma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as selinexor and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving selinexor, carfilzomib, and dexamethasone may be a better treatment for ...
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Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.
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Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants with Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
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CC-220-MM-001: A Phase 1b/2a Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple Myeloma
Scottsdale/Phoenix, AZ
This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT) and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
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STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
Scottsdale/Phoenix, AZ
The main objective of this study is to describe and evaluate safety and effectiveness of MBG453 (sabatolimab) in combination with FDA approved Hypomethylating Agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI)).
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A Study to Evaluate the Safety, Tolerance and Anti-tumor Activity of SAR442257 in Patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Non-Hodgkin Lymphoma
Rochester, MN
The primary purpose of this study is to determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D).
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Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant
Jacksonville, FL
This phase I/II trial studies the best dose and side effects of ibrutinib when given together with lenalidomide and dexamethasone and how well they work in treating patients with multiple myeloma that are not eligible for transplant. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, lenalidomide, and dexamethasone may work better in ...
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Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the proportion of confirmed responses (complete response, partial response), and hematologic improvement as defined by revised IWG criteria during the 12 months of treatment.
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A Study to Evaluate CC-98633 to Treat Subjects with Relapsed and/or Refractory Multiple Myeloma
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this Phase 1 first-in human study is to evaluate the safety and preliminary efficacy of CC-98633 in adult subjects with relapsed and/or refractory MM. A challenge in CAR T-cell development is to generate a product that consistently expands, persists, and mediates durable antitumor responses after infusion. Multiple preclinical and translational studies have suggested that the differentiation state of adoptively transferred T cells can influence the ability of these cells to persist and promote durable antitumor immunity. Less differentiated T cells have shown an increased ability to proliferate, persist, and mediate responses in mouse tumor models compared to more differentiated effector memory cell subsets in certain studies.
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Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant
Rochester, MN
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
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A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration
Eau Claire, WI; Rochester, MN; Scottsdale/Phoenix, AZ
The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.
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Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem cell transplantation works in treating patients with multiple myeloma that has come back or does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone, before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem ...
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Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Jacksonville, FL; Rochester, MN
Does idasanutlin in combination with ixazomib and dexamethasone contribute to better outcomes for patients with multiple myeloma who have been previously treated for their disease?
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A Study to Evaluate the Combination of Selinexor with Pomalidomide and Dexamethasone +/- Carfilzomib to Treat Patients with Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate selinexor combined with carfilzomib, pomalidomide and dexamethasone or pomalidomide and dexamethasone for the treatment of relapsed refractory multiple myeloma.
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Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of the ALLO-605-201 study is to assess the safety, effectiveness, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma
Jacksonville, FL
This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose/optimum biological dose of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 ...
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Genetically Engineered Cells (MUC1-Activated T-Cells) for the Treatment of MUC1 Positive Recurrent or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
Primary Goal: To determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing multiple myeloma.
The rationale for using MUC1-stimulated T-cells to treat multiple myeloma is twofold. The first is that T-cell therapies have been shown to be active in myeloma, making it an attractive disease model for the proposed study. The other is that we are expanding and using naturally occurring myeloma-fighting T-cells which may offer benefits, particularly with respect to longevity, as compared to the methods currently being employed using CAR-T and bispecific antibodies. This is highly significant as one of the ...
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A Study to Evaluate Effectiveness and Quality of Life Outcomes of Daratumumab in Relapsed/Refractory Multiple Myeloma Patients
Rochester, MN
The primary purpose of this study is to evaluate patient-reported health-related quality of life outcomes in subjects with Relapsed/Refractory Multiple Myeloma (RRMM) treated with daratumumab-based regimens in a real life setting.
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ACP-196 in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
Rochester, MN; Jacksonville, FL
The purpose of this study is to characterize the safety profile of acalabrutinib and pembrolizumab in subjects with hematologic malignancies.
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Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this trial is to identify the RP2D of STI-6129 by assessing the safety, preliminary effectiveness and pharmacokinetics in treating subjects with relapsed/refractory multiple myeloma (RRMM).
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A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this phase 3, randomized, double-blind, multicenter study is to compare Oral Ixazomib (MLN9708) plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.
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Financial Difficulty in Patients With Blood Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze the financial difficulties experienced by patients undergoing treatment for multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). It is composed of a patient survey (n=250), a physician survey (n=100), and a practice survey completed by each site enrolling patients onto this study. A subset of enrolled patients (n=35) will be invited to participate in an optional second telephone interview (Appendix D). This study will measure the prevalence of patient-reported financial difficulty, specific financial burdens and resources currently available to patients and from practices to assist with patient financial navigation.
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An Efficacy Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the effect of ixazomib+dexamethasone (ixa+dex) versus pomalidomide+dexamethasone (pom+dex) on progression-free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to lenalidomide but not refractory to proteasome inhibitors.
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A Study to Evaluate Immune and Hematopoietic Cell Assessment in Clonal B Cell Conditions
Rochester, MN
The purpose of this study is to evaluate the immune and hematopoietic compartments in patients with monoclonal B cell lymphocytosis (MBL) and chronic lymphocytic leukemia (CLL) in comparison to age-matched healthy control (HC) donors.
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A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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PET imaging with [18F]BF4
Rochester, MN
The objectives of the study are to determine the biodistribution of [18F]BF4 (TFB F 18 Injection) in patients with myeloma or endometrial cancer being treated with oncoviruses carrying the NIS reporter gene.
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A Study to Assess Financial Burden and Its Impact on Quality of Life in Patients with Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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KTX-100 MMSET Catalytic Inhibitor that Suppresses H3K36me2 in Patients with Relapsed and Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and schedule and/or a recommended Phase 2 dose (RP2D) and schedule of KTX-1001 for patients with relapsed and refractory multiple myeloma.
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A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).
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A Study to Evaluate Pembrolizumab, Ixazomib Citrate, and Dexamethasone to Treat Participants with Relapsed Multiple Myeloma
Rochester, MN
This phase II trial studies how well pembrolizumab works when given together with ixazomib citrate and dexamethasone in treating participants with multiple myeloma that has come back. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together ...
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A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383.
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Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction
No Locations
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used ...
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A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Rochester, MN
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
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A Study of WVT078 in Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Rochester, MN
This phase I/II trial studies the side effects and best dose of venetoclax when given together with ixazomib citrate and dexamethasone and to see how well they work in treating patients with multiple myeloma that has come back. Venetoclax and ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with ixazomib citrate and ...
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A Study to Evaluate CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work ...
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SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Jacksonville, FL
The purpose of this study is to demonstrate the efficacy non-inferiority between isatuximab SC and isatuximab IV in combination with pomalidomide and dexamethasone (Pd), and to demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd.
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Study of BMF-219, in Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), and Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy (Cohorts 1, 2, 3, and 4).
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A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
Rochester, MN
The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, we will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is our overall ...
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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
Rochester, MN
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the ...
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Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
Rochester, MN
The purpose of this study is to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.
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Myeloma Referral Study (Race, Ethnicity, and Familial Etiologic Relationship, Risk Association, and Linkage Study)
Rochester, MN
The goal of the present study is to answer the question of whether there are clinically relevant subtypes of monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma (MM) that are associated with populations at high risk for developing these conditions using an online survey and submission of de-identified medical information.
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A Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of CFT7455 administered orally in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) administered once a day (QD) as a single agent and in combination with dexamethasone.
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Study to Evaluate CCS1477 in Haematological Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is primarily designed to evaluate the safety and tolerability of CCS1477 in patients with relapsed or refractory acute myeloid leukaemia (AML)/high-risk myelodysplastic syndrome (MDS), multiple myeloma (MM) and non-Hodgkin lymphoma (NHL; B or T-cell).
CCS1477 is a potent, selective and orally bioavailable inhibitor of the bromodomain of p300 and CBP, critical transcriptional co-activators of genes that drive cell proliferation and survival. The compound causes G1 cell cycle arrest and is anti-proliferative across a broad range of haematological cell models, representative of AML, MM and lymphomas. This is also accompanied by an increase in myeloid differentiation in ...
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A Study of CART-TnMUC1 in Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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Global Cardio Oncology Registry
Rochester, MN
The purpose of this study is to provide a large database and platform for prospective sub-studies and eventually develop additional collaborations with a platform for clinical studies and trials following the initial pilot phase.
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A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
Rochester, MN
The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.