A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorC4 Therapeutics, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of myeloma in the central nervous system (CNS).
Systemic light chain amyloidosis
Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
Myelodysplastic syndrome (MDS).
Trial design
Design model
Single group
Treatments tested in this trial
Cemsidomide
Drugdosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
Dexamethasone
Drugdosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Cemsidomide + Dexamethasone:Experimental treatment 2 interventions
Trial outcomes
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 monthsSecondary outcomes
1
Duration of response (DoR; IRC assessed)
Time frame
up to approximately 43 months2
Complete response (CR) rate (IRC assessed)
Time frame
up to approximately 43 months3
Time to response (IRC assessed)
Time frame
up to approximately 43 months4
Progression free survival (PFS; IRC assessed)
Time frame
up to approximately 43 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov