A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma
18 Years and older, Male and Female
GO42552 (primary)
NCI-2021-07543
2021-000238-33
Summary
This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab
plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone
(Dd) which will be administered to participants with relapsed or refractory multiple
myeloma (R/R MM) via intravenous (IV) infusion.
Eligibility
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Agreement to provide bone marrow biopsy and aspirate samples
- Resolution of adverse events from prior anti-cancer therapy to Grade <=1
- Measurable disease
- For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria
- Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria
- For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment
- For Cohort B2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of treatment
- Agreement to comply with all requirements of the pomalidomide pregnancy prevention program
- For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered
- For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria
- For Cohort C1S: Participants with R/R MM who have received at least two prior lines of treatment
- For Cohort C2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of therapy
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered
- For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period
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