A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participan… (NCT06934044) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participants With Relapsed or Refractory Multiple Myeloma
China20 participantsStarted 2025-05-13
Plain-language summary
This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 (…
What they're measuring
1
Serum Concentration of Cevostamab at Specified Timepoints
Timeframe: Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days
2
Percentage of Participants with Adverse Events
Timeframe: Baseline up to approximately 2 years
Trial details
NCT IDNCT06934044
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-11-04
Contact for this trial
Reference Study ID Number: YO43835 https://forpatients.roche.com/