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

a study on Multiple Myeloma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

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

Keywords

Multiple Myeloma (MM), multiple myeloma, cemsidomide, CFT7455, elranatamab, PF-06863135, relapsed, refractory, RRMM, BCMA, bispecific antibody, BiTE, TCE, ELREXFIO, Multiple Myeloma, Recurrence, Bites and Stings, Cemsidomide, Elranatamab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Health, Jonsson Comprehensive Cancer Center
    Santa Monica California 90404 United States
  • Banner MD Anderson Cancer Center
    Gilbert Arizona 85234 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
C4 Therapeutics, Inc.
ID
NCT07280013
Phase
Phase 1 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated