EUCTR2013-005525-23-SE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 560
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 be at least 18 years of age.
- •2. 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.
- •3. Subject must have received at least 1 prior line of therapy for multiple myeloma (refer to Attachment 1).
- •4. 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 (refer to Attachment 1).
- •5. 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.
- •6. Subject must have an ECOG Performance Status score of 0, 1, or 2 (refer to Attachment 2).
- •7. For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have resolved or
- •stabilized to =Grade 1.
- •8. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device [IUD], hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male
- •latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing. Reliable contraception is indicated
- •even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.
- •9. A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to
- •dosing and the second within 24 hours prior to dosing. For requirements during the Treatment Phase, please see Section 4.3.
- •10. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands
- •the purpose of and procedures required for the study and are willing to participate in the study. Subjects must be willing and able to adhere to
- •the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
- •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.If previously treated with a lenalidomide-containing regimen, the subject is excluded if he or she:
- •? Discontinued due to any adverse event related to prior lenalidomide treatment (history of thromboembolism due to lenalidomide is allowed if
- •subject is anticoagulated per the American Society of Clinical Oncology [ASCO] 2013 guideline) (Lyman 2013)26,or
- •?If, at any time point, the subject was refractory to any dose of lenalidomide. Refractory to lenalidomide is defined either:
- •-Subjects whose disease progresses within 60 days after the last dose of lenalidomide;or
- •-Subjects whose disease is nonresponsive while on lenalidomide.Nonresponsive disease is defined as either failure to achieve at least an MR or development of PD while on 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. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (SIPPM).
- •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 either of the following:
- •a) Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note
- •that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is <50% of predicted normal
- •b) Known moderate or severe persistent asthma, within the past 2 years (see Attachment 9), uncontrolled asthma of any classification. Note that
- •subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study
- •9.Subject is known to be seropositive for human immunodeficiency virus (HIV), known to have hepatitis B surface antigen positivity, or known to
- •have a history of hepatitis C.
- •10. Subject has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures or
- •results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
- •11.Subject has clinically significant cardiac disease,including:
- •?Myocardial infarction within 6 months before Cycle1,Day1,or unstable or uncontrolled disease/condition related to or affecting cardiac function
- •(eg, unstable angina, congestive h
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