A Study to Evaluate Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple myeloma (MM)MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503689-21-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 135
??Agreement to provide protocol-specific bone marrow biopsy and aspirate samples, ??Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, ??Life expectancy of at least 12 weeks, ??Documented diagnosis of MM according to the International Myeloma Working Group (IMWG) diagnostic criteria, ??Evidence of progressive disease based on Investigator’s determination of response by IMWG criteria on or after last dosing regimen, ??Participants with r/r MM who previously received therapy, including an immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). Both anti-CD38 naïve and anti-CD38 exposed/refractory participants are allowed
??Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of forimtamig, tocilizumab, or carfilzomib, or 102 days after the last dose of daratumumab, ??Plasma cell leukemia with circulating plasma cell count = 5% or >500/µL, ??Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis, ??Participants with current amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy), ??Participants with myelodysplastic syndrome, ??Participants with (extramedullary) lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare. Participants may be eligible after discussion with the Medical Monitor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method