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NCT07280013 | RECRUITING | Multiple Myeloma (MM)

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

C4 Therapeutics, Inc.

Brief 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.

Condition or disease

Multiple Myeloma (MM)

Intervention/treatment

Cemsidomide

Elranatamab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2029-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects

Location Details

NCT07280013

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, arizona, United States, 85234

NOT YET RECRUITING

United States, California

UCLA Health, Jonsson Comprehensive Cancer Center

Santa Monica, California, United States, 90404

NOT YET RECRUITING

United States, Georgia

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

NOT YET RECRUITING

United States, Kentucky

Norton Cancer Institute St. Matthews

Louisville, Kentucky, United States, 40207

NOT YET RECRUITING

United States, Maryland

University of Maryland Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

RECRUITING

United States, road cancer

START Midwest

Grand Rapids, road cancer, United States, 49546

NOT YET RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

NOT YET RECRUITING

United States, North Carolina

Duke Cancer Center

Durham, North Carolina, United States, 27710

NOT YET RECRUITING

United States, Tennessee

Tennessee Oncology

Nashville, Tennessee, United States, 37203

NOT YET RECRUITING

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030

NOT YET RECRUITING

United States, Utah

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

NOT YET RECRUITING

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226