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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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

ArmDescriptionAssigned 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.
  • Drug: Cemsidomide
    dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
  • Drug: Dexamethasone
    dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

Recruiting Locations

HonorHealth
Scottsdale, Arizona 85258
Contact:
Rizwan Khawaja, MD

Berenson Cancer Center
West Hollywood, California 90069
Contact:
James Berenson, MD

Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Contact:
Nisha Joseph, MD

Indiana University Health
Indianapolis, Indiana 46202
Contact:
Attaya Suvannasankha, MD

START Midwest
Grand Rapids, Michigan 49546
Contact:
Andrew Sochacki, MD

Washington University/Siteman Cancer Center
St Louis, Missouri 63108
Contact:
Mark Schroeder, MD

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Sarah Holstein, MD

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Hamza Hashmi, MD

START San Antonio
San Antonio, Texas 78229
Contact:
Kyriakos Papadopoulos, MD

University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin 53792
Contact:
Natalie Callander, MD

More Details

Status
Recruiting
Sponsor
C4 Therapeutics, Inc.

Study Contact

Study Medical Officer
(617) 231-0700
clinicaltrials@c4therapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.