A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
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
1 other identifier
interventional
60
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2026
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedStudy Start
First participant enrolled
February 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
April 17, 2026
April 1, 2026
2.8 years
December 1, 2025
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of cemsidomide in combination with elranatamab
Dose limiting toxicity rate
Cycle 1 approximately 28 days
Safety and tolerability of cemsidomide in combination with elranatamab
Frequency and severity of AEs
Baseline through 30 days after discontinuation of study treatment
Secondary Outcomes (4)
Assess antimyeloma activity
Approximately 2 years
Evaluate the PK of cemsidomide and elranatamab
Approximately 4 months
Evaluate the PK of cemsidomide and elranatamab
Approximately 2 years
Assess the immunogenicity of elranatamab
Approximately 2 years
Study Arms (1)
Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection)
EXPERIMENTALInterventions
IKZF1/3 degrader
• BCMA-CD3 bispecific antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
UCLA Health, Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Norton Cancer Institute St. Matthews
Louisville, Kentucky, 40207, United States
University of Maryland Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
University of Nebraska
Omaha, Nebraska, 68105, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Perlmutter Cancer Center at NYU Langone Hospital
Brooklyn, New York, 11203, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2025
First Posted
December 12, 2025
Study Start
February 6, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share