A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (CAMMA 1)
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2031230660
- Lead Sponsor
- Tina Nielsen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 184
Participants with R/R MM who have received at least 1 prior line of treatment
-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-Measurable disease
-Agreement to provide bone marrow biopsy and aspirate samples
-Resolution of adverse events from prior anti-cancer therapy to Grade <=1
-Meet the other eligibility criteria as defined in the protocol.
-Inability to comply with protocol-mandated hospitalization and activities restrictions
-Prior allogeneic SCT
-Circulating plasma cell count exceeding 500/uL or 5% of the peripheral blood white cells
-History of other malignancy within 2 years before screening
-Positive and quantifiable EBV PCR or CMV PCR before first study treatment
-Significant cardiovascular disease
-Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate 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-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment
-Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment
-Treatment with radiotherapy within 4 weeks (systemic) or 14 days (focal) before first study treatment
-Treatment with any chemotherapeutic agent or other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
-ASCT within 100 days before first study treatment
-Meet the other exclusion criteria as defined in the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method