Evaluating a new combination treatment for relapsed or refractory multiple myeloma
An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma
PHASE1 · Genentech, Inc. · NCT05927571
This study is testing a new combination of two treatments for people with relapsed or refractory multiple myeloma to see if it's safe and how well it works.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. (industry) |
| Drugs / interventions | cevostamab, elranatamab |
| Locations | 14 sites (Camperdown, New South Wales and 13 other locations) |
| Trial ID | NCT05927571 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of combining cevostamab and elranatamab in patients with relapsed or refractory multiple myeloma. It includes a safety lead-in stage followed by an expansion stage to determine the recommended Phase II dose for the treatment. Participants will be monitored for pharmacokinetics and overall activity of the drug combination. The study is designed to provide insights into the effectiveness of this novel treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with relapsed or refractory multiple myeloma who meet specific health criteria.
Not a fit: Patients who have previously received cevostamab or elranatamab, or those with certain comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with relapsed or refractory multiple myeloma.
How similar studies have performed: While this approach is novel, similar studies targeting multiple myeloma have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Diagnosis of R/R MM per IMWG criteria * For female participants of childbearing potential: agreement to remain abstinent or use contraception * For male participants: agreement to remain abstinent or use a condom Exclusion Criteria: * Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5) * Prior treatment with elranatamab * Prior allogeneic stem cell transplantation (SCT) * Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells * Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome * Participants with known history of amyloidosis * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * Peripheral motor polyneuropathy of prespecified grade * Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection * Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Human immunodeficiency virus (HIV) seropositivity * History of central nervous system (CNS) myeloma disease * Significant cardiovascular disease
Where this trial is running
Camperdown, New South Wales and 13 other locations
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (RECRUITING)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (RECRUITING)
- Royal Adelaide Hospital;Haematology Clinical Trials Unit — Adelaide, South Australia, Australia (RECRUITING)
- St. Vincent's Hospital Melbourne — Melbourne, Victoria, Australia (RECRUITING)
- The Alfred Hospital — Prahan, Victoria, Australia (RECRUITING)
- The Chaim Sheba Medical Center - PPDS — Ramat Gan, Central District, Israel (RECRUITING)
- Rambam Health Care Campus — Haifa, Israel (RECRUITING)
- Hadassah University Hospital - Ein Kerem — Jerusalem, Israel (RECRUITING)
- Tel Aviv Sourasky Medical Center PPDS — Tel Aviv, Israel (RECRUITING)
- The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) — Seocho, South Korea (RECRUITING)
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (RECRUITING)
- Asan Medical Center. — Seoul, South Korea (RECRUITING)
- Samsung Medical Center - PPDS — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: GO43979 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsed or Refractory Multiple Myeloma