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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment100 people
  • Recruiting US sites23
  • SponsorC4 Therapeutics, Inc.
  • RegistryNCT07284758

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma: a one-minute explainerNCT072847581 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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 cannot join 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.
  • NOTE: Other inclusion/exclusion criteria may apply, per protocol.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

cemsidomide. An orally bioavailable modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities. Upon oral administration, cemsidomide specifically binds to cereblon (CRBN), thereby affecting the ubiquitin E3 ligase activity, and targeting certain substrate proteins for ubiquitination. This induces proteasome-mediated degradation of certain transcription factors, including Ikaros (IKZF1) and Aiolos (IKZF3), which are transcriptional repressors in T cells. This reduces the levels of these transcription factors, and modulates the activity of the immune system, which may include the activation of T lymphocytes. This also leads to downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. CRBN, the substrate recognition component of the CRL4-CRBN E3 ubiquitin ligase complex, plays a key role in the ubiquitination of certain proteins. NCI Drug Dictionary

Treatments listed in the registry

  • Cemsidomide (Drug): dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
  • Dexamethasone (Drug): dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

The study

Treatment groups

Na · Single Group · masking: None

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.

Goals

What the study measures

Main goals

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

Other goals

  • Duration of response (DoR; IRC assessed)
  • Complete response (CR) rate (IRC assessed)
  • Time to response (IRC assessed)
  • Progression free survival (PFS; IRC assessed)
  • Overall survival (OS)
  • Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths
  • Plasma concentrations of cemsidomide

Planned enrollment: 100 (estimated).

Where

Recruiting US sites

  • Clearview Cancer Institute, Huntsville, Alabama
  • Mayo Clinic - Arizona, Phoenix, Arizona
  • HonorHealth, Scottsdale, Arizona
  • City of Hope, Duarte, California
  • Berenson Cancer Center, West Hollywood, California
  • Mayo Clinic - Florida, Jacksonville, Florida
  • Winship Cancer Institute, Emory University, Atlanta, Georgia
  • Indiana University Health, Indianapolis, Indiana
  • University of Iowa, Iowa City, Iowa
  • Massachusetts General Hospital, Boston, Massachusetts
  • University of Michigan, Ann Arbor, Michigan
  • Karmanos Cancer Institute, Detroit, Michigan
  • START Midwest, Grand Rapids, Michigan
  • Mayo Clinic - Minnesota, Rochester, Minnesota
  • Washington University/Siteman Cancer Center, St Louis, Missouri
  • University of Nebraska Medical Center, Omaha, Nebraska
  • The Tisch Cancer Institute/Mount Sinai, New York, New York
  • Memorial Sloan Kettering Cancer Center, New York, New York
  • UNC Hospitals Adult Oncology Clinics, Chapel Hill, North Carolina
  • Tennessee Oncology, Nashville, Tennessee
  • START San Antonio, San Antonio, Texas
  • University of Wisconsin - Carbone Cancer Center, Madison, Wisconsin
  • MCW-Clinical Cancer Center at Froedtert Hospital Campus, Milwaukee, Wisconsin

10 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 5, 2026. Public record; not medical advice.

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