Relapsed or Refractory Multiple Myeloma
Conditions
Brief summary
The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.
Interventions
DRUGCevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
DRUGElranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
DRUGTocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From signing of informed consent up to end of study (EOS) (approximately 36 months) | Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). The severity of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Scales. |
| Recommended Phase II Regimen (RP2R) | Up to approximately 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria | Up to approximately 36 months |
| Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria | Up to approximately 36 months |
| Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria | Up to approximately 36 months |
| Progression-Free Survival as Determined by the Investigator per IMWG Criteria | Up to approximately 36 months |
| Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better) | Up to approximately 36 months |
| Time to First Response (for Participants who Achieve a Response of PR or Better) | Up to approximately 36 months |
| Time to Best Response (for Participants who Achieve a Response of PR or Better) | Up to approximately 36 months |
| Overall Survival (OS) | Up to approximately 36 months |
| Serum Concentration of Cevostamab at Specified Timepoints | Up to approximately 36 months |
| Serum Concentration of Elranatamab at Specified Timepoints | Up to approximately 36 months |
| Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab | Up to approximately 36 months |
| Number of Participants with ADA Against Elranatamab | Up to approximately 36 months |
Countries
Australia, Israel, South Korea
Contacts
CONTACTGO43979 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed