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A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04910568
Protocol IDs
GO42552 (primary)
NCI-2021-07543
2021-000238-33
Study Sponsor
Genentech Inc.

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

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  2. Life expectancy of at least 12 weeks
  3. Agreement to provide bone marrow biopsy and aspirate samples
  4. Resolution of adverse events from prior anti-cancer therapy to Grade <=1
  5. Measurable disease
  6. For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 2 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered
  7. 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 cevostamab or tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria
  8. 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
  9. For Cohort B1S: Patients with R/R MM who have received at least 2 prior lines of treatment
  10. For Cohort B1E: Patients with R/R MM who have received at least 1 prior line of treatment
  11. Agreement to comply with all local requirements of the pomalidomide pregnancy risk minimization plan
  12. 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
  13. 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, and agreement to refrain from donating sperm during this same period Additional Arm C-Specific Inclusion Criteria
  14. For Cohort C1S: Patients with R/R MM who have received at least 2 prior lines of treatment
  15. For Cohort C1E: Patients with R/R MM who have received at least 1 prior line of therapy
  16. For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 3 months after the last dose of daratumumab was administered
  17. For men: agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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