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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of multiple myeloma as defined by IMWG criteria

• Measurable disease based on IMWG criteria

• Received 1-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader)

• ECOG performance status 0-2

Locations
United States
Arizona
Banner MD Anderson Cancer Center
NOT_YET_RECRUITING
Gilbert
California
UCLA Health, Jonsson Comprehensive Cancer Center
NOT_YET_RECRUITING
Santa Monica
Georgia
Winship Cancer Institute, Emory University
NOT_YET_RECRUITING
Atlanta
Kentucky
Norton Cancer Institute St. Matthews
NOT_YET_RECRUITING
Louisville
Maryland
University of Maryland Greenbaum Comprehensive Cancer Center
NOT_YET_RECRUITING
Baltimore
Michigan
START Midwest
RECRUITING
Grand Rapids
North Carolina
Duke Cancer Center
NOT_YET_RECRUITING
Durham
New York
Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITING
New York
Tennessee
Tennessee Oncology
NOT_YET_RECRUITING
Nashville
Texas
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Utah
Huntsman Cancer Institute, University of Utah
NOT_YET_RECRUITING
Salt Lake City
Wisconsin
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Contact Information
Primary
Study Medical Officer
clinicaltrials@c4therapeutics.com
(617) 231-0700
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2029-06
Participants
Target number of participants: 60
Treatments
Experimental: Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection)
Related Therapeutic Areas
Sponsors
Leads: C4 Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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