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Recruiting Phase 1 NCT07280013

A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects

Phase 1 – testing safety in a small group of people
Conditions: Multiple Myeloma (MM)

Sponsor: C4 Therapeutics, Inc.

trial.available_in: БГ
Overview
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma. The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity. Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
Who can participate
Inclusion Criteria: * 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, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader) * ECOG performance status 0-2 Exclusion Criteria: * 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 * Participants with any active, uncontrolled bacterial, fungal, or viral infection * Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy * Administration with an investigational product within 30 days preceding the first dose of study intervention * Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
Interventions
Cemsidomide
DRUG
Elranatamab
BIOLOGICAL
Locations 16
United States (16)
Winship Cancer Institute, Emory University
Atlanta , Georgia
University of Maryland Greenbaum Comprehensive Cancer Center
Baltimore , Maryland
NOT_YET_RECRUITING
Perlmutter Cancer Center at NYU Langone Hospital
Brooklyn , New York
NOT_YET_RECRUITING
Duke Cancer Center
Durham , North Carolina
NOT_YET_RECRUITING
Banner MD Anderson Cancer Center
Gilbert , Arizona
NOT_YET_RECRUITING
START Midwest
Grand Rapids , Michigan
MD Anderson Cancer Center
Houston , Texas
NOT_YET_RECRUITING
Indiana University
Indianapolis , Indiana
NOT_YET_RECRUITING
Dartmouth-Hitchcock Medical Center
Lebanon , New Hampshire
NOT_YET_RECRUITING
Norton Cancer Institute St. Matthews
Louisville , Kentucky
NOT_YET_RECRUITING
Loyola University Medical Center
Maywood , Illinois
NOT_YET_RECRUITING
Memorial Sloan Kettering Cancer Center
New York , New York
NOT_YET_RECRUITING
University of Nebraska
Omaha , Nebraska
NOT_YET_RECRUITING
Huntsman Cancer Institute, University of Utah
Salt Lake City , Utah
NOT_YET_RECRUITING
UCLA Health, Jonsson Comprehensive Cancer Center
Santa Monica , California
NOT_YET_RECRUITING
Tampa General Hospital
Tampa , Florida
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.02.2026
Completion date
01.06.2029
Registry ID
NCT07280013
Source
clinicaltrials.gov
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