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

NCT ID: NCT07284758

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cemsidomide + Dexamethasone:

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.

Group Type: EXPERIMENTAL

Cemsidomide

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Interventions

Cemsidomide

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Be willing and able to provide signed informed consent for the study.

2. Age ≥ 18 years at the time of signed consent.

3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.

4. 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.

5. Subjects need to have adequate organ function.

6. Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.

7. 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.

8. 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.

9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.

10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.

Exclusion Criteria

1. Presence of myeloma in the central nervous system (CNS).

2. Subjects with any of the following:

• Systemic light chain amyloidosis
• Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
• Myelodysplastic syndrome (MDS).

3. Previously treated with cemsidomide.

4. Clinically significant impaired cardiac function or cardiac disease.

5. Thromboembolic event within 3 months prior to enrollment.

6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.

7. Uncontrolled active bacterial, fungal, or viral infection.

8. Inability or difficulty swallowing tablets.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C4 Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binod Dhakal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Martin Kaiser, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Royal Marsden

Aurore Perrot, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universite de Toulouse

Locations

Berenson Cancer Center

West Hollywood, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Medical Officer

Role: CONTACT

clinicaltrials@c4therapeutics.com

(617) 231-0700

Facility Contacts

James Berenson, MD

Role: primary

Other Identifiers

CFT7455-2101

Identifier Type: -

Identifier Source: org_study_id