A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Trial Parameters
Brief Summary
This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.
Eligibility Criteria
Inclusion Criteria: 1. 18 to 75 years of age (inclusive of critical values), either gender. 2. The subject was previously diagnosed with multiple myeloma and had received 1-2 lines of therapy (including chemotherapy regimens based on proteasome inhibitors and immunomodulatory agents, with each line of therapy receiving at least 1 full cycle ; Documented disease progression during or within 12 months after the most recent anti-myeloma therapy. 3. Subjects was lenalidomide-refractory during prior therapy. 4. ECOG score of 0 or 1. 5. Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment: (1) Haematology: absolute neutrophil count (ANC) ≥1×10\^9/L (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10\^9/L; Platelets ≥50×10\^9 / L (must not have received platelet transfusion within 7 days prior to laboratory test