Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
cemsidomide, dexamethasone, Multiple Myeloma
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).
Interventions
DRUGCemsidomide
dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
DRUGDexamethasone
dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle
Sponsors
C4 Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) | up to approximately 43 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom, United States
Contacts
CONTACTStudy Medical Officer
PRINCIPAL_INVESTIGATORBinod Dhakal, M.D.
Medical College of Wisconsin
PRINCIPAL_INVESTIGATORMartin Kaiser, M.D.
The Royal Marsden
PRINCIPAL_INVESTIGATORAurore Perrot, M.D.
Universite de Toulouse
Outcome results
None listed