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
Clearview Cancer Institute
Huntsville, Alabama 35805
Huntsville, Alabama 35805
Contact:
Lakshmikanth Katragadda, MD
Lakshmikanth Katragadda, MD
Mayo Clinic - Arizona
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Saurabh Chhabra, MD
Saurabh Chhabra, MD
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
Mayo Clinic - Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Contact:
Sikander Ailawadhi, MD
Sikander Ailawadhi, 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
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Contact:
Christopher Strouse, MD
Christopher Strouse, MD
Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Contact:
Craig Cole, MD
Craig Cole, MD
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Contact:
Andrew Sochacki, MD
Andrew Sochacki, MD
Mayo Clinic - Minnesota
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Wilson Gonsalves, MD
Wilson Gonsalves, 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
The Tisch Cancer Institute/Mount Sinai
New York, New York 10029
New York, New York 10029
Contact:
Shambavi Richard, MD
Shambavi Richard, MD
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Hamza Hashmi, MD
Hamza Hashmi, MD
UNC Hospitals Adult Oncology Clinics
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Contact:
Sascha Tuchman, MD
Sascha Tuchman, MD
Tennessee Oncology
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, MD
Jesus Berdeja, 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
MCW-Clinical Cancer Center at Froedtert Hospital Campus
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Binod Dhakal, MD
Binod Dhakal, MD
More Details
- Status
- Recruiting
- Sponsor
- C4 Therapeutics, Inc.