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

Date Added
January 11th, 2022
PRO Number
Pro00116527
Researcher
Hamza Hashmi

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
Hamza Hashmi

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

Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lonalidomide as Post-Autologous STem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration

Date Added
November 6th, 2019
PRO Number
Pro00094224
Researcher
Hamza Hashmi

List of Studies

Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with multiple myeloma. The investigational drugs in this study are lenalidomide and daratumumab. The purpose of this study is to compare overall survival between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma patients. Participants can expect to be on this study for up to 7 years. After 7 years, participants may be followed by telephone for up to 15 years from the time they started study treatment.

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

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Date Added
July 29th, 2019
PRO Number
Pro00090904
Researcher
Amarendra Neppalli

List of Studies


Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with smoldering multiple myeloma (SMM). The drugs used in this study are daratumumab, lenalidomide and dexamethasone which are all commercially used drugs. The purpose of this study is to compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab revlimid-dexamethasone or revlimid-dexamethasone. Participants can expect to be on this study for up to two years and followed by your doctor for up to 15 years.

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



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