Actively Recruiting
A Phase 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Led by C4 Therapeutics, Inc. · Updated on 2026-04-17
60
Participants Needed
16
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of cemsidomide combined with elranatamab in people with relapsed or refractory multiple myeloma. This Phase 1B, open-label study aims to find safe dose levels and explore preliminary anti-myeloma activity. The study is sponsored by C4 Therapeutics, Inc. and involves participants who have received prior treatments for multiple myeloma. The study involves taking cemsidomide orally for 14 days followed by 14 days off in a 28-day cycle. Elranatamab is given by subcutaneous injection twice a month. Dexamethasone is also given weekly for up to 4 cycles or until a confirmed response. Initially, different dose levels of cemsidomide will be tested in a small group, followed by an expansion phase to enroll more participants at the safe dose level. Participants will undergo safety and tolerability assessments during the first 28-day cycle and for 30 days after stopping treatment. Additional evaluations include measuring anti-myeloma activity over about two years, pharmacokinetics of both drugs, and immunogenicity of elranatamab. The study includes clinical exams, laboratory tests, and monitoring for side effects throughout treatment and follow-up periods, with total participation lasting up to several years.
CONDITIONS
Brief Title
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma as defined by IMWG criteria
- Measurable disease based on IMWG criteria
- Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, including at least 1 immunomodulatory drug
- ECOG performance status 0-2
You will not qualify if you...
- Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
- Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- Any active, uncontrolled bacterial, fungal, or viral infection
- Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
- Use of an investigational product within 30 days before first dose
- Inability or difficulty swallowing tablets, malabsorption syndrome, or significant gastrointestinal dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive cemsidomide tablets combined with subcutaneous injections of elranatamab as part of their therapy for relapsed/refractory multiple myeloma.
Weekly visits for up to 4 months, then less frequent visits as determined by the study team
Duration - Up to approximately 2 years after treatment ends
Participants are monitored for safety, tolerability, antimyeloma activity, pharmacokinetics, and immunogenicity after completing treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 16 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Not Yet Recruiting
2
UCLA Health, Jonsson Comprehensive Cancer Center
Santa Monica, California, United States, 90404
Not Yet Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Not Yet Recruiting
4
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Not Yet Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
7
Norton Cancer Institute St. Matthews
Louisville, Kentucky, United States, 40207
Not Yet Recruiting
8
University of Maryland Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
9
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
10
University of Nebraska
Omaha, Nebraska, United States, 68105
Not Yet Recruiting
11
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Not Yet Recruiting
12
Perlmutter Cancer Center at NYU Langone Hospital
Brooklyn, New York, United States, 11203
Not Yet Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Not Yet Recruiting
14
Duke Cancer Center
Durham, North Carolina, United States, 27710
Not Yet Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
16
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
Research Team
S
Study Medical Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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