Rafael Fonseca, M.D.

Closed for Enrollment

• A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  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.

• A Phase I/II, Open-Label, Multi-Cohort Study to Evaluate the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen-Exposed Patients With Relapsed/Refractory Multiple Myeloma (CAMMA 2) Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).

• A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Regimens and Molecular Profiles (CoMMpass) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

• An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of cevostamab (BFCR4350A) in Patients With Relapsed or Refractory Multiple Myeloma Scottsdale/Phoenix, Ariz.

  This is a phase I, multicenter, open-label, dose-escalation study of cevostamab (BFCR4350A) administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).

• Artificial Intelligence Enhanced ECG to detect Cardiac Amyloidosis: Protocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY) (PREDICT-AMY) Rochester, Minn., Jacksonville, Fla., Eau Claire, Wis., Scottsdale/Phoenix, Ariz.

  This pragmatic trial will be the first study to prospectively evaluate the use of the AI ECG dashboard along with an augmented report in everyday practice.   The findings will also guide future implementation strategies and inform the translation of many of the current and future AI algorithms into the clinical setting. The participants are the providers/clinicians. Basic demographic information about the providers will be collected as well as their reactions to the trial based educational guidance supplied to them. Patient health information will be collected on their patients using a HIPPA waiver. There will be no patient contact.   We will reveiew 29,000 ekgs.

• C1071009: MAGNETISMM-9, A Phase 1/2, Open-label, Multicenter Study to Evaluate a Dosing Regimen with Two Step-up Priming Doses and Longer Dosing Intervals of Elranatamab (PF-06863135) Monotherapy in Patients with Relapsed/Refractory Multiple Myeloma (MagnetisMM-9) Scottsdale/Phoenix, Ariz.

  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 week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

• CAEL101-302 A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis (CAEL101-302) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine if CAEL-101 improves the overall survival in patients with cardiac AL Amyloidosis.

   

   

• MC210809, Evaluating Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  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.

• Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma Scottsdale/Phoenix, Ariz.

  This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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.