A Phase 3 Randomized Study Comparing Talquetamab in Combination With Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Date Added
February 6th, 2024
PRO Number
Pro00133322
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Men's Health, Women's Health
Summary

The study is for a patient that have been diagnosed with multiple myeloma. The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first).

Institution
MUSC
Recruitment Contact
Shanta Salzer
8437929300
salzers@musc.edu

EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Date Added
January 11th, 2022
PRO Number
Pro00116527
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Cancer/Myeloma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with multiple myeloma. The investigational drug in this study is idecabtagene vicleucel (ide-cel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to have about 8 clinic visits and to be in this study for up to 3 months after receiving the study drug and in follow up for up to 15 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Date Added
September 28th, 2021
PRO Number
Pro00115401
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with multiple myeloma. The usual approach for patients with newly diagnosed multiple myeloma who are not in a study, is lenalidomide and dexamethasone in combination with bortezomib or daratumumab. This approach is approved by the Food and Drug Administration (FDA). The purpose of this study is to see if patients who have a small amount of cancer left after initial treatment (called minimal residual disease (MRD)), could benefit from adding a new drug to the usual treatment. The study approach, using a combination of four drugs, is investigational and not approved by the FDA. Patients can expect to be on this study for up to 2 years. Patients will then be followed by their doctor for up to 15 years after completion of the study or until disease progression..

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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