A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
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
2 other identifiers
interventional
120
3 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
August 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
May 4, 2026
May 1, 2026
4 years
June 22, 2023
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Events (AEs)
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.
From signing of informed consent up to end of study (EOS) (approximately 36 months)
Recommended Phase II Regimen (RP2R)
Up to approximately 36 months
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (3)
Safety Lead-In Cohort
EXPERIMENTALParticipants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Dose Expansion Cohort (Combined Therapy)
EXPERIMENTALParticipants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Dose Expansion Cohort (Monotherapy)
EXPERIMENTALParticipants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity.
Interventions
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (14)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Royal Adelaide Hospital;Haematology Clinical Trials Unit
Adelaide, South Australia, 5000, Australia
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
The Alfred Hospital
Prahan, Victoria, 3181, Australia
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, 5262100, Israel
Rambam Health Care Campus
Haifa, 3109600, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 6423906, Israel
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, 06591, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center.
Seoul, 05505, South Korea
Samsung Medical Center - PPDS
Seoul, 06351, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
GO43979 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
July 3, 2023
Study Start
August 10, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing