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

Sponsor
Hoffmann-La Roche
Study ID
NCT06934044
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cevostamab — DRUG
    Cevostamab will be administered intravenously on a 21-day cycle.
  • Tocilizumab — DRUG
    Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Study Details

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

Key Dates

Start date
May 13, 2025
Status verified
Jun 2026
Primary completion
Nov 15, 2028
Completion
Nov 15, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Serum Concentration of Cevostamab at Specified Timepoints [ Time Frame: Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days ]

Central Contacts

  • Reference Study ID Number: YO43835 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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