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Digital Storytelling Intervention for Cancer Patients Undergoing Hematopoietic Cell Transplantation
Scottsdale/Phoenix, AZ
The study is testing the effectiveness of digital story intervention in caregivers of patients who have recently undergone transplant for hematopoietic cell malignancies. Research has shown that viewing presentation of HCT stories from individuals who have similar experiences with their diagnosis and treatment and have a wide range of emotional expression or resolutions have beneficial effects on emotional wellbeing. We will use the information from this study to help us to evaluate the use of this intervention to minimize emotional distress among HCT caregivers.
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A Study to Evaluate the Use of a Novel Wearable Device for Temperature Monitoring in Cancer Patients Who Underwent Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to evaluate the performance of the wearable tPatch device when compared to an oral temperature measuring device in patients who have undergone a post-autologous bone marrow transplant.
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A Study to Evaluate and Compare Effectiveness Among New Measuring Methods to Find Minimal Residual Disease Following Stem Cell Transplant for Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate and compare the effectiveness of new methods of measuring more accurately for minimal residual disease following bone marrow/stem cell transplant in patients who have multiple myeloma. The study will also assess patient perceived quality of life in connection to the use of intensive treatments.
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A Study to Examine and Report the Physical Performance Capabilities of Patients Receiving Hematopoietic Cell Transplantation
Rochester, MN
The purpose of this study is to examine and report the physical performance capabilities of patients receiving hematopoietic cell transplantation. The primary research question is: how does hematopoietic cell transplantation affect patients' physical performance?
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A Study to Explore Quality of Life According to Treatment Plan for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With MM
Rochester, MN
A total of 207 subjects will be randomized into the study which will employ a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
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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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A Study to Evaluate Clinical Performance of the Aptima® CMV Quant Assay on the Panther® System
Rochester, MN
The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).
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A Study of a Wearable Vital Signs Monitoring Device for the Detection of Systemic Inflammatory Response Syndrome and Sepsis in Stem Cell Transplant Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to validate the effectiveness of the ZephyrLife Home monitoring device compared with standard ICU or stepdown vital signs monitoring, especially for heart rate, respiratory rate and temperature as systemic (whole body) inflammatory response syndrome or sepsis ( whole body infection) markers in stem cell transplant patients.
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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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A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
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DALY 2.0 USA/ MB-CART2019.1 for DLBCL
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the effectiveness of MB-CART2019.1 cells administered following a conditioning lymphodepletion regimen in diffuse large B cell lymphoma (DLBCL) subjects who failed at least two lines of therapy as measured by objective response rate (ORR) at one month.
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Patient and Caregiver Experience of Bone Marrow Transplant
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to collect both survey and qualitative data from patients and caregivers in order to obtain descriptive data necessary to formulate and develop future empirical studies and intervention efforts that address bone marrow transplant (BMT) patient/caregiver well-being.
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A Study to Evaluate the Role of Gut Microbiome in Cancer Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to correlate gut microbiome with specific cancer diagnoses and the clinical response (effectiveness), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.
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Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Rochester, MN
The purpose of this trial is to compare the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
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A Study of Outcomes for Patients and Caregivers Receiving Bone Marrow Transplant (BMT) by Providing a Caregiving Educational Intervention
Rochester, MN
The goal of this project is to improve outcomes for patients receiving bone marrow transplant (BMT) and their caregivers by providing a caregiving educational intervention.
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Study for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
Rochester, MN
The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.
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Safety of BM-MNC Intramyocardial Delivery in Ebstein RV
Rochester, MN
The objective of this study is to evaluate the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) delivered into the myocardium of the right ventricle of subjects with Ebstein anomaly undergoing surgical Ebstein repair. Additionally, the potential cardiovascular benefits will also be evaluated. This add-on procedure is anticipated to pose little risk to the subject and has the potential to foster a new strategy that leverages the regenerative capacity of individuals with congenital heart disease during the surgically mandated Ebstein repair.
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A Study to Develop Novel Tools for Post-HCT Respiratory Complications
Rochester, MN
The purpose of this study is to develop tools to better predict which patients will be at highest risk of lung complications following bone marrow transplantation.
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A Study to Evaluate Cancer Distress, Psychological Trauma, and Resiliency in Hospitalized Hematopoietic Stem Cell Transplant Patients
Jacksonville, FL
The purpose of this study is to better understand the distress experience of hospitalized patients undergoing hematopoietic stem cell transplant (HSCT), and to examine the relationship between cancer distress, psychological trauma, and resiliency over time.
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Coping with Hematopoietic Stem Cell Transplantation and Psychosocial
Scottsdale/Phoenix, AZ
The purpose of this study is to develop digital, personal narrative stories about hematopoietic stem cell transplantation (HCT) with a sample of HCT caregivers.
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A Study to Evaluate Quality of Life Over Time in Patients Treated with CAR-T Cell Therapy Compared with Stem Cell Transplantation in Hematologic Malignancies
Rochester, MN
The purpose of this study is to evaluate quality of life over time in patients treated with CAR-T therapy compared with autologous and allogeneic stem cell transplant.
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Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission
Rochester, MN; Jacksonville, FL
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy 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. ...
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A Study to Determine the Effects of COVID-19 in Cancer Patients
Scottsdale/Phoenix, AZ; Mankato, MN; La Crosse, WI; Eau Claire, WI; Rochester, MN
The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.
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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 ...