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NCT Number: NCT07280013

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

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.

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Key information

Conditions

Multiple Myeloma (MM) Bites and Stings Blood Protein Disorders Cardiovascular Diseases Chemically-Induced Disorders Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Recurrence Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cemsidomide

Drug

IKZF1/3 degrader

Elranatamab

Biological
  • BCMA-CD3 bispecific antibody

Other names: o PF-06863135 o ELREXFIO

Primary outcomes

  1. Safety and tolerability of cemsidomide in combination with elranatamab

    Time frame: Cycle 1 approximately 28 days

    Dose limiting toxicity rate

  2. Safety and tolerability of cemsidomide in combination with elranatamab

    Time frame: Baseline through 30 days after discontinuation of study treatment

    Frequency and severity of AEs

Secondary outcomes

  1. Assess antimyeloma activity

    Time frame: Approximately 2 years

    Objective Response Rate (ORR) per IMWG criteria

  2. Evaluate the PK of cemsidomide and elranatamab

    Time frame: Approximately 4 months

    Pre and post dose concentrations of cemsidomide

  3. Evaluate the PK of cemsidomide and elranatamab

    Time frame: Approximately 2 years

    Pre dose concentrations of elranatamab

  4. Assess the immunogenicity of elranatamab

    Time frame: Approximately 2 years

    Percent of participants with positive anti-drug antibodies to elranatamab

Study contacts

Contact information is provided by the study sponsor or research team.

Study Medical Officer

CONTACT

[email protected]

(617) 231-0700

Sponsors and collaborators

Lead sponsor

C4 Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 12, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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