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Recruiting NCT07280013

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

Phase I Interventional Multiple Myeloma (MM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cemsidomide, Elranatamab.
Who it may be relevant to
Registry conditions: Multiple Myeloma (MM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Cemsidomide
    IKZF1/3 degrader
  • Biological Elranatamab
    • BCMA-CD3 bispecific antibody

Primary outcome measures

  • Safety and tolerability of cemsidomide in combination with elranatamab [Time frame: Cycle 1 approximately 28 days]
  • Safety and tolerability of cemsidomide in combination with elranatamab [Time frame: Baseline through 30 days after discontinuation of study treatment]
Secondary outcome measures (4)
  • Assess antimyeloma activity [Time frame: Approximately 2 years]
  • Evaluate the PK of cemsidomide and elranatamab [Time frame: Approximately 4 months]
  • Evaluate the PK of cemsidomide and elranatamab [Time frame: Approximately 2 years]
  • Assess the immunogenicity of elranatamab [Time frame: Approximately 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 20 centers
  • Banner MD Anderson Cancer Center — Gilbert
  • UC Davis Comprehensive Cancer Center — Sacramento
  • UCLA Health, Jonsson Comprehensive Cancer Center — Santa Monica
  • University of Florida — Gainesville
  • University of Miami — Miami
  • Winship Cancer Institute, Emory University — Atlanta
  • Loyola University Medical Center — Maywood
  • Indiana University — Indianapolis
  • … and 12 more centers

Identifiers

NCT: NCT07280013 · CFT7455-1102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗