to evaluate the efficacy and safety of ql2109 and darzalex faspro® in multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with pomalidomide + ql2109 + dexamethasone compared with pomalidomide + darzalex faspro® + dexamethasone in the participants with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * males and females at least 18 years of age. * subject must have measurable disease of mm as defined by the criteria below:serum m-protein level ≥0.5 g/dl or urine m-protein level ≥200 mg/24 hours; or light chain multiple myeloma, for subjects without measurable disease in the serum or urine: serum immunoglobulin free light chain (flc) ≥10 mg/dl and abnormal serum immunoglobulin kappa lambda flc ratio. * subjects must have received prior antimyeloma treatment. the prior treatment must have included both a pi- and lenalidomide-containing regimens. subjects who received only 1 line of prior treatment must have demonstrated pd on or within 60 days of completion of the lenalidomide containing regimen (ie, lenalidomide refractory). * subjects must have documented evidence of pd based on the investigator's determination of response as defined by the modified imwg criteria on or after the last regimen. * eastern cooperative oncology group (ecog) performance status score of ≤ 2. * for subjects experiencing toxicities resulting from previous therapy, the toxicities must be resolved or stabilized to ≤grade 1. * any of the following laboratory test results during screening: 1. absolute neutrophil count ≥1.0 × 109/l; 2. hemoglobin level ≥75 g/l (≥4.65 mmol/l); (transfusions are not permitted to reach this level); 3. platelet count ≥75 × 109/l in subjects in whom \<50% of bone marrow nucleated cells are plasma cells and platelet count ≥50 x 109/l in subjects in whom ≥50% of bone marrow nucleated cells are plasma cells; 4. alanine aminotransferase (alt) level ≤2.5 times the upper limit of normal (uln);aspartate aminotransferase (ast) level ≤2.5 x uln; 5. total bilirubin level ≤1.5 x uln, (except for gilbert syndrome: direct bilirubin ≤1.5 × uln); 6. creatinine clearance ≥30 ml/min 7. serum calcium corrected for albumin ≤14.0 mg/dl (≤3.5 mmol/l), or free ionized calcium ≤ 6.5 mg/dl (≤1.6 mmol/l). exclusion criteria: * subject has plasma cell leukemia (\>2.0 × 109/l circulating plasma cells by standard differential) or waldenström's macroglobulinemia or poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis. * history of malignancy (other than mm) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years). * clinical signs of meningeal involvement of mm. * previous therapy with any anti-cd38 monoclonal antibody. * previous exposure to pomalidomide. * subject has received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. the only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment before cycle 1, day 1 (c1d1). * previous allogenic stem cell transplant; or autologous stem cell transplantation (asct) within 12 weeks before c1d1. * subject has had major surgery within 2 weeks before randomization, or has not fully recovered from an earlier surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration. * ongoing ≥ grade 2 peripheral neuropathy. * subject had ≥grade 3 rash during prior therapy. * pregnant or nursing women.