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

NCT06934044 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YO43835
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Serum Concentration of Cevostamab at Specified Timepoints

  Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days

• Percentage of Participants with Adverse Events

  Baseline up to approximately 2 years

Secondary Outcomes (14)

• Objective Response Rate (ORR)

  Baseline up to approximately 2 years

• Rate of Complete Response (CR) or Better

  Baseline up to approximately 2 years

• Rate of Very Good Partial Response (VGPR) or Better

  Baseline up to approximately 2 years

• Duration of Response (DOR)

  Baseline up to approximately 2 years

• Progression-free Survival (PFS)

  Start of study treatment to first date of disease progression, relapse or death from any cause, whichever occurs first (up to approximately 2 years)

Study Arms (1)

Cevostamab

EXPERIMENTAL

Participants will receive cevostamab administered by intravenous (IV) infusion in 21-day cycles.

Drug: Cevostamab; Drug: Tocilizumab

Interventions

Cevostamab DRUG

Cevostamab will be administered intravenously on a 21-day cycle.

Cevostamab

Tocilizumab DRUG

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Cevostamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of MM based on standard International Myeloma Working Group (IMWG) criteria
• Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen
• Current relapsed or refractory (R/R) disease status
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy of at least 12 weeks
• Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol
• Resolution of AEs from prior anti-cancer therapy to Grade =\< 1 or better
• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 5 months after the final dose of cevostamab and for 3 months after the last dose of tocilizumab was administered
• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 2 months after the final dose of tocilizumab (if applicable) to avoid exposing the embryo

You may not qualify if:

• Unable to comply with protocol-mandated hospitalization
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or tocilizumab or within 3 months after the last dose of tocilizumab (if applicable)
• Prior treatment with cevostamab or another agent with the same target
• Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
• Prior treatment with systemic immunotherapeutic agents, including but not limited to, cytokine therapy and anti-CTLA-4, anti-PD-1, and anti-PD-L1
• Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion
• Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
• Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
• Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment
• Prior allogeneic SCT
• Prior solid organ transplantation
• History of autoimmune disease
• History of confirmed progressive multifocal leukoencephalopathy
• History of severe allergic or anaphylactic reactions to mAb therapy
• Known history of amyloidosis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Tianjin Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 301636, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035, China

RECRUITING

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: YO43835 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 18, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): November 4, 2028
• Study Completion (Estimated): November 4, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)