NCT07284758RecruitingPhase 2
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
C4 Therapeutics, Inc.21 sites in 2 countries100 target enrollmentStarted: February 18, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- C4 Therapeutics, Inc.
- Enrollment
- 100
- Locations
- 21
- Primary Endpoint
- Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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.
Intervention: Cemsidomide (Drug)
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.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
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
- 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)
- Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths(within 30 to 35 days of the last dose of study treatment)
- Plasma concentrations of cemsidomide(up to approximately 4 months)
Investigators
Study Sites (21)
Loading locations...
Similar Trials
Not yet recruiting
Phase 1
Study of TYK-01054 Capsules in Patients With Advanced Solid TumorsNCT07282873TYK Medicines, Inc219
Recruiting
Phase 1
A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast CancerNCT07281976Nanjing Leads Biolabs Co.,Ltd220
Active, not recruiting
Phase 1/2
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anticancer agents in patients with HER2-positive Metastatic Breast Cancer inclusive of patients with active and stable brain metastases2023-505309-18-00AstraZeneca AB46
Recruiting
Phase 1
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal TumorsNCT07263594DualityBio Inc.127
Not yet recruiting
Phase 2
A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung CancerNCT07283198Jiangsu Alphamab Biopharmaceuticals Co., Ltd160