Relapsed or Refractory Multiple Myeloma
Estado: No Reclutando AúnA Phase 3, randomized, multicenter, open-label study to evaluate the efficacy and safety of Alnuctamab compared to standard of care regimens in participants with relapsed or refractory Multiple Myeloma (RRMM).
Principales Criterios de Inclusión:
• Documented diagnosis of multiple myeloma with measurable disease:
– M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or
– M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP), or
– Serum free light chain (FLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in participants without detectable M-protein in serum or urine
• 1-3 prior lines of anti-myeloma therapy
• Prior treatment with lenalidomide & anti-CD38 mAb
• Achieved a minimal response (MR) or better to at least 1 prior anti-myeloma therapy
• Documented disease progression during or after the last anti-myeloma therapy or failure to achieve response with the last anti-myeloma therapy.
• ECOG performance status score of 0, 1, or 2
- Laboratorio:Bristol Myers Squibb
- Área Terapéutica:
- Fase del estudio:III
- Código de Estudio:CA058-1019
- FALP
- Sanatorio Alemán
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