A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT07284758 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CFT7455-2101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).

Conditions

Multiple Myeloma; Relapsed/Refractory Multiple Myeloma

Keywords

cemsidomide; dexamethasone; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)

  up to approximately 43 months

Secondary Outcomes (7)

• Duration of response (DoR; IRC assessed)

  up to approximately 43 months

• Complete response (CR) rate (IRC assessed)

  up to approximately 43 months

• Time to response (IRC assessed)

  up to approximately 43 months

• Progression free survival (PFS; IRC assessed)

  up to approximately 43 months

• Overall survival (OS)

  up to approximately 43 months

Study Arms (1)

Cemsidomide + Dexamethasone:

EXPERIMENTAL

Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria.

Drug: Cemsidomide; Drug: Dexamethasone

Interventions

Cemsidomide DRUG

dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle

Cemsidomide + Dexamethasone:

Dexamethasone DRUG

dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

Cemsidomide + Dexamethasone:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide signed informed consent for the study.
• Age ≥ 18 years at the time of signed consent.
• Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
• Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.
• Subjects need to have adequate organ function.
• Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.
• Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.
• Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.
• Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
• Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.

You may not qualify if:

• Presence of myeloma in the central nervous system (CNS).
• Subjects with any of the following:
• Systemic light chain amyloidosis
• Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
• Myelodysplastic syndrome (MDS).
• Previously treated with cemsidomide.
• Clinically significant impaired cardiac function or cardiac disease.
• Thromboembolic event within 3 months prior to enrollment.
• Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
• Uncontrolled active bacterial, fungal, or viral infection.
• Inability or difficulty swallowing tablets.

Sponsors & Collaborators

• C4 Therapeutics, Inc.: lead

Study Sites (3)

Berenson Cancer Center

West Hollywood, California, 90069, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Binod Dhakal, M.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Martin Kaiser, M.D.

  The Royal Marsden

  PRINCIPAL INVESTIGATOR

• Aurore Perrot, M.D.

  Universite de Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Medical Officer

CONTACT

(617) 231-0700; clinicaltrials@c4therapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)