Recruiting
Phase 2

Cemsidomide & Dexamethasone

Sponsor:

C4 Therapeutics, Inc.

Code:

NCT07284758

Conditions

Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cemsidomide

Dexamethasone

Study Details

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 ID

NCT07284758

Start date

Feb 18, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

NOTE: Other inclusion/exclusion criteria may apply, per protocol.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Cemsidomide

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

Dexamethasone

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

Primary outcome measure

  • Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) [ Time Frame: up to approximately 43 months ]

Central Contacts and Locations

Central contacts

Locations

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805

Mayo Clinic - Arizona

Recruiting

Phoenix, Arizona, United States, 85054

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Berenson Cancer Center

Recruiting

West Hollywood, California, United States, 90069

Mayo Clinic - Florida

Recruiting

Jacksonville, Florida, United States, 32224

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Mayo Clinic - Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Washington University/Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

The Tisch Cancer Institute/Mount Sinai

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

UNC Hospitals Adult Oncology Clinics

Recruiting

Chapel Hill, North Carolina, United States, 27514

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

University of Wisconsin - Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

MCW-Clinical Cancer Center at Froedtert Hospital Campus

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

C4 Therapeutics, Inc.

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • cemsidomide
  • dexamethasone
  • Multiple Myeloma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by C4 Therapeutics, Inc. on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.