Cemsidomide plus elranatamab for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study tests escalating oral doses of cemsidomide given 14 days on/14 days off in combination with subcutaneous elranatamab administered twice monthly to determine safety and tolerability in patients with relapsed or refractory multiple myeloma. The trial begins with a dose-escalation portion exploring about three dose levels of cemsidomide, followed by an expansion cohort at a selected safe dose to further evaluate tolerability and early anti-myeloma activity. Dexamethasone is given weekly for up to four cycles until a confirmed response, and participants must have measurable disease and meet prior-therapy requirements. Key exclusion criteria include prior BCMA-directed T-cell engager or CAR-T therapy, recent transplant, active uncontrolled infections, and certain plasma cell disorders.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• UC Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• UCLA Health, Jonsson Comprehensive Cancer Center
  Santa Monica, California, United States Recruiting
• Winship Cancer Institute, Emory University
  Atlanta, Georgia, United States Recruiting
• Norton Cancer Institute St. Matthews
  Louisville, Kentucky, United States Recruiting
• University of Maryland Greenbaum Comprehensive Cancer Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Study Medical Officer
• Email: clinicaltrials@c4therapeutics.com
• Phone: (617) 231-0700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Elranatamab given as outpatient in relapsed or refractory multiple myeloma

  This study tests a bispecific antibody called elranatamab, given in an outpatient setting to adults with relapsed or refractory multiple myeloma who have had prior therapies.

  Recruiting at 6 sites Phase 2 SCRI Development Innovations, LLC · Denver, Colorado and 5 other locations · NCT07637578

• Cognitive changes after BCMA CAR-T in multiple myeloma

  This study tests whether cognitive function changes over time in adults with relapsed or refractory multiple myeloma who receive BCMA CAR-T therapy.

  Recruiting Wake Forest University Health Sciences · Charlotte, North Carolina · NCT07740317

• GPRC5D-targeted PET/CT imaging in plasma cell disorders

  This study tests a new GPRC5D-targeted PET/CT imaging method in adults with plasma cell disorders to see if it detects disease better or differently than standard imaging.

  Recruiting Phase 1 Peking University First Hospital · Beijing, Beijing Municipality · NCT07660939

• Gustabor: Tailored AI Nutrition for Taste Changes During Cancer Therapy

  This trial tests whether personalized, AI-assisted dietary advice helps people with taste changes from cancer treatment compare to general dietary guidance.

  Recruiting at 2 sites Wuerzburg University Hospital · Augsburg, Bavaria and 5 other locations · NCT07649681

• Personalising Myeloma Treatment Based on Initial Response and Fitness

  This trial tests whether adjusting treatment after six months of the standard DRd therapy, based on a patient’s response and fitness, can improve outcomes for older, transplant-ineligible patients with myeloma.

  Recruiting Phase 3 University of Leeds · Bristol and 4 other locations · NCT07649525

• Elranatamab consolidation for newly diagnosed plasmablastic lymphoma

  This study tests whether giving Elranatamab after initial chemotherapy can help patients with plasmablastic lymphoma, with or without HIV, stay in remission.

  Recruiting Phase 1 University of Illinois Chicago · Chicago, Illinois · NCT07647432

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.