EUCTR2013-005525-23-PL进行中（未招募）1 期
Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 569
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must have documented multiple myeloma as defined by the
- •criteria below:
- •? Monoclonal plasma cells in the bone marrow =10% at some point in their disease history or presence of a biopsy proven plasmacytoma.
- •? Measurable disease as defined by any of the following:
- •- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours; or
- •- IgA, IgD, IgE, IgM multiple myeloma: serum M-protein level =0.5 g/dL or urine M-protein level =200 mg/24 hours; or
- •- Light chain multiple myeloma without measurable disease in the
- •serum or the urine: Serum immunoglobulin free light chain =10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- •2. Subject must have received at least 1 prior line of therapy for multiple myeloma.
- •3. Subject must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
- •4. Subject must have documented evidence of progressive disease (PD) based on investigator's determination of response by the IMWG criteria on or after their last regimen.
- •5. Subject must have an ECOG Performance Status score of 0, 1, or 2.
- •Please refer to protocol for complete overview of inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •1. Subject has received daratumumab or other anti-CD38 therapies previously.
- •2. Subject's disease shows evidence of refractoriness or intolerance to lenalidomide.
- •3.Subject has received anti-myeloma 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 4 days) before treatment. 4.Subject has received ASCT within 12 weeks before the date of randomization,or the subject has previously received an allogenic stem cell transplant (regardless of timing)
- •5.Subjects planning to undergo a stem cell transplant prior to progression of disease on this study,ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant
- •6.Subject has a history of malignancy (other than multiple myeloma) within 5 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 5 years)
- •7. Subject has known meningeal involvement of multiple myeloma
- •8.Subject has any of the following laboratory test results during the Screening Phase:
- •-Absolute neutrophil count =1.0 × 109/L
- •- Hemoglobin level =7.5 g/dL (=5 mmol/L) (it is not permissible to transfuse a subject to reach this level)
- •- Platelet count <75 × 109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count <50 ×109/L (it is not permissible to transfuse a subject to reach this level)
- •-Aspartate aminotransferase (AST)or alanine aminotransferase level (ALT) =2.5 times the upper limit of normal (ULN)
- •-Alkaline phosphatase level =2.5 × ULN
- •-Total bilirubin level =1.5 × ULN,(except for Gilbert Syndrome: direct bilirubin 1.5 ×ULN)
- •-Creatinine clearance <30 mL/min (for lenalidomide dose adjustment for
- •subjects with creatinine clearance 30-60 mL/min, please see Section 6.5).Calculated creatinine clearance may be calculated using the Cockcroft-Gault formula, Modification of Diet in Renal Disease (MDRD),or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (see Attachment 3)
- •- Corrected Serum calcium >14.0 mg/dL (>3.5 mmol/L) or free ionized calcium >6.5 mg/dL (>1.6 mmol/L).
- •9. 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.
- •Please refer to protocol for complete overview of exclusion criteria.
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