A Phase Ib, Open-Label, Single-Arm, Multicenter Trial Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Patients With Relapsed or Refractory Multiple Myeloma

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sun yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Tianjin Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Reference Study ID Number: YO43835 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2028-05-08
Participants
Target number of participants: 20
Treatments
Experimental: Cevostamab
Participants will receive cevostamab administered by intravenous (IV) infusion in 21-day cycles.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov