NCT06742138尚未招募3 期
A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase III Clinical Study to Evaluate QL2109/ DARZALEX FASPRO® in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 284
- 主要终点
- Percentage of Participants With Very Good Partial Response (VGPR) or Better
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •For subjects experiencing toxicities resulting from previous therapy, the toxicities must be resolved or stabilized to ≤Grade
- •Any of the following laboratory test results during Screening:
- •Absolute neutrophil count ≥1.0 × 109/L;
- •Hemoglobin level ≥75 g/L (≥4.65 mmol/L); (transfusions are not permitted to reach this level);
- •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;
- •Alanine aminotransferase (ALT) level ≤2.5 times the upper limit of normal (ULN);Aspartate aminotransferase (AST) level ≤2.5 x ULN;
- •Total bilirubin level ≤1.5 x ULN, (except for Gilbert Syndrome: direct bilirubin ≤1.5 × ULN);
- •Creatinine clearance ≥30 mL/min
- •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).
排除标准
- •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 C1D
- •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.
研究组 & 干预措施
Pomalidomide Plus(+) QL2109 + Dexamethasone
Experimental
干预措施: QL2109 (Drug)
Pomalidomide Plus(+) QL2109 + Dexamethasone
Experimental
干预措施: Pomalidomide (Drug)
Pomalidomide Plus(+) QL2109 + Dexamethasone
Experimental
干预措施: Dexamethasone (Drug)
Pomalidomide + DARZALEX FASPRO® + Dexamethasone
Active Comparator
干预措施: Pomalidomide (Drug)
Pomalidomide + DARZALEX FASPRO® + Dexamethasone
Active Comparator
干预措施: Dexamethasone (Drug)
Pomalidomide + DARZALEX FASPRO® + Dexamethasone
Active Comparator
干预措施: DARZALEX FASPRO® (Drug)
结局指标
主要结局
Percentage of Participants With Very Good Partial Response (VGPR) or Better
时间窗: from baseline to week 24
VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) according to the IMWG criteria during or after the study treatment.
次要结局
- Percentage of Participants With Very Good Partial Response (VGPR) or Better(from baseline to week 12 and week 48)
- Overall Response Rate(from baseline to week 24 and week 48)
- Overall survival at 18 months(from baseline to 18 months)
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