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NCT Number: NCT07284758

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HonorHealth, Scottsdale, 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

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration of response (DoR; IRC assessed)

    Time frame: up to approximately 43 months

  2. Complete response (CR) rate (IRC assessed)

    Time frame: up to approximately 43 months

  3. Time to response (IRC assessed)

    Time frame: up to approximately 43 months

  4. Progression free survival (PFS; IRC assessed)

    Time frame: up to approximately 43 months

  5. Overall survival (OS)

    Time frame: up to approximately 43 months

  6. Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths

    Time frame: within 30 to 35 days of the last dose of study treatment

  7. Plasma concentrations of cemsidomide

    Time frame: up to approximately 4 months

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 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Acronym: MOMENTUM

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 16, 2025
Registry last updated
Jul 1, 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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