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)

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927571
• Other study ID #: GO43979
• Secondary ID: 2023-504657-13-0
• Status: Recruiting
• Phase: Phase 1
• Start date: August 10, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: GO43979 https://forpatients.roche.com/
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 dose (RP2D) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• Cevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
• Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
• Tocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Prahan	Victoria
Israel	Rambam Health Care Campus	Haifa
Israel	Sheba Medical Center - PPDS	Ramat Gan
Korea, Republic of	The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)	Seocho
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

Australia,  Israel,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria		Up to approximately 36 months
Secondary	Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria		Up to approximately 36 months
Secondary	Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria		Up to approximately 36 months
Secondary	Progression-Free Survival as Determined by the Investigator per IMWG Criteria		Up to approximately 36 months
Secondary	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
Secondary	Time to First Response (for Participants who Achieve a Response of PR or Better)		Up to approximately 36 months
Secondary	Time to Best Response (for Participants who Achieve a Response of PR or Better)		Up to approximately 36 months
Secondary	Overall Survival (OS)		Up to approximately 36 months
Secondary	Serum Concentration of Cevostamab at Specified Timepoints		Up to approximately 36 months
Secondary	Serum Concentration of Elranatamab at Specified Timepoints		Up to approximately 36 months
Secondary	Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab		Up to approximately 36 months
Secondary	Number of Participants with ADA Against Elranatamab		Up to approximately 36 months