A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Purpose
This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
Conditions
- Multiple Myeloma
- Relapsed/Refractory Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Be willing and able to provide signed informed consent for the study. 2. Age ≥ 18 years at the time of signed consent. 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. 4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care. 5. Subjects need to have adequate organ function. 6. Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1. 7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment. 8. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment. 9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation. 10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
Exclusion Criteria
- Presence of myeloma in the central nervous system (CNS). 2. Subjects with any of the following: - Systemic light chain amyloidosis - Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome - Myelodysplastic syndrome (MDS). 3. Previously treated with cemsidomide. 4. Clinically significant impaired cardiac function or cardiac disease. 5. Thromboembolic event within 3 months prior to enrollment. 6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years. 7. Uncontrolled active bacterial, fungal, or viral infection. 8. Inability or difficulty swallowing tablets. NOTE: Other inclusion/exclusion criteria may apply, per protocol.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cemsidomide + Dexamethasone: |
Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria. |
|
Recruiting Locations
HonorHealth
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Contact:
Rizwan Khawaja, MD
Rizwan Khawaja, MD
Berenson Cancer Center
West Hollywood, California 90069
West Hollywood, California 90069
Contact:
James Berenson, MD
James Berenson, MD
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Nisha Joseph, MD
Nisha Joseph, MD
Indiana University Health
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Contact:
Attaya Suvannasankha, MD
Attaya Suvannasankha, MD
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Contact:
Andrew Sochacki, MD
Andrew Sochacki, MD
Washington University/Siteman Cancer Center
St Louis, Missouri 63108
St Louis, Missouri 63108
Contact:
Mark Schroeder, MD
Mark Schroeder, MD
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Contact:
Sarah Holstein, MD
Sarah Holstein, MD
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Hamza Hashmi, MD
Hamza Hashmi, MD
START San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
Contact:
Kyriakos Papadopoulos, MD
Kyriakos Papadopoulos, MD
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Contact:
Natalie Callander, MD
Natalie Callander, MD
More Details
- Status
- Recruiting
- Sponsor
- C4 Therapeutics, Inc.