Actively Recruiting
A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participants With Relapsed or Refractory Multiple Myeloma
Led by Hoffmann-La Roche · Updated on 2026-05-11
20
Participants Needed
5
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
CONDITIONS
Official Title
A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of multiple myeloma based on standard IMWG criteria
- Evidence of progressive disease based on investigator's determination by IMWG criteria after last treatment
- Current relapsed or refractory 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
- Resolution of adverse events from prior anti-cancer therapy to Grade 1 or better
- Female participants of childbearing potential must agree to remain abstinent or use contraception during treatment and for at least 5 months after last cevostamab dose and 3 months after last tocilizumab dose
- Male participants must agree to remain abstinent or use a condom and not donate sperm during treatment and for at least 2 months after last tocilizumab dose if applicable
You will not qualify if you...
- Unable to comply with protocol-mandated hospitalization
- Pregnancy or breastfeeding, or intention to become pregnant during study or within 5 months after last cevostamab or tocilizumab dose
- Prior treatment with cevostamab or another agent targeting the same molecule
- Prior monoclonal antibody, radioimmunoconjugate, or ADC therapy within 4 weeks before study treatment, except non-myeloma therapies
- Prior systemic immunotherapy including cytokine therapy or checkpoint inhibitors
- Prior CAR-T therapy within 12 weeks before first cevostamab infusion
- Known immune-related adverse events from prior checkpoint inhibitors
- Recent radiotherapy, chemotherapy, or other anti-cancer treatment within 4 weeks or 5 drug half-lives before study treatment
- Autologous stem cell transplant within 100 days before study treatment
- Prior allogeneic stem cell or solid organ transplantation
- History of autoimmune disease or progressive multifocal leukoencephalopathy
- Severe allergic reactions to monoclonal antibody therapy
- Known amyloidosis
- Tumor lesions near vital organs risking sudden deterioration
- History of other cancer within 2 years except certain low-risk types
- Central nervous system disease history or involvement
- Significant cardiovascular or active pulmonary disease
- Active infections including COVID-19 or recent IV antimicrobial or antiviral treatment
- Positive Epstein-Barr virus or cytomegalovirus PCR prior to study
- Known chronic active EBV infection
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- History of severe cytokine release syndrome or neurotoxicity with prior bispecific therapies
- Major surgery within 4 weeks before study
- Positive tests for hepatitis B or C
- Known HIV infection
- Live attenuated vaccine within 4 weeks before study or planned during study
- Systemic immunosuppressive medications within 2 weeks except low-dose corticosteroids
- History of illicit drug or alcohol abuse within 12 months
- Any medical condition or abnormal tests that may affect safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 301636
Actively Recruiting
3
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
4
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325035
Actively Recruiting
5
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
Research Team
R
Reference Study ID Number: YO43835 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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