EUCTR2010-020347-12-DK进行中（未招募）1 期
A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 640
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) Signed Written Informed Consent
- •a) Subject is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- •b) Subject has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- •2) Target Population
- •a) Age >or= 18 years or legal age of consent per local regulations
- •b) ECOG performance status c) Life-expectancy > 3 months
- •d) Documented evidence of multiple myeloma and
- •i) Received between 1 to 3 prior lines of therapy with documented progression by EBMT criteria after the most recent therapy AND
- •ii) Measurable disease (subject must meet one of the following 5 criteria):
- •(a) serum IgG M-protein >or= 0.5 g/dL
- •(b) serum IgA M-protein >or= 0.5 g/dL
- •(c) serum IgM M-protein >or= 0.5 g/dL
- •(d) serum IgD M-protein >or= 0.05 g/dL
- •(e) Urine M-protein >or= 200 mg/24-hour
- •e) Prior lenalidomide exposure is permitted only if they fulfill all of the following:
- •i) Best response achieved was >or= PR
- •ii) Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide or within 9 months of last dose of lenalidomide
- •iii) Subject did not discontinue lenalidomide due to a Grade >or= 3 related AE
- •iv) Subject did not receive more than 9 cycles of lenalidomide and had at least 9 months between the last dose of lenalidomide and progression
- •3) Age and Reproductive Status
- •a) Men and women of childbearing potential (WOCBP) must be using 2 acceptable methods of contraception to avoid pregnancy throughout the study for a period of at least 1 month (4 weeks) before and women for up to 8 weeks, men for up to 90 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
- •b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). The first should be performed within 10 - 14 days and the second within 24 hours prior to the start of the investigational product. A prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
- •c) Women must not be breastfeeding.
- •d) Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP, even if they have had a successful vasectomy, and must agree to not donate semen during study drug therapy and for 90 days after therapy.
- •e) Subjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapy.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 540
排除标准
- •1) Target Disease Exceptions
- •a) Subjects with non-secretory or oligo-secretory or serum free lightchain only myeloma (subjects with measurable M protein only in the urine as defined under Inclusion Criteria would be eligible)
- •b) Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
- •2) Medical History and Concurrent Diseases
- •a) All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade b) POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •c) Significant cardiac disease as determined by the investigator including:
- •i) Known or suspected cardiac amyloidosis
- •ii) Congestive heart failure of Class III or IV of the NYHA classification;
- •iii) Uncontrolled angina, hypertension or arrhythmia
- •iv) Myocardial infarction in past 6 months
- •v) Any uncontrolled or severe cardiovascular disease
- •d) Prior cerebrovascular event with persistent neurologic deficit
- •e) Known HIV infection or active hepatitis A, B, or C
- •f) Any medical conditions that, in the investigator's opinion, would impose excessive risk to the subject. Examples of such conditions include:
- •i) Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder
- •ii) Active infection that requires parenteral anti-infective treatment
- •iii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent
- •g) Prior or concurrent malignancy, except for the following:
- •i) Adequately treated basal cell or squamous cell skin cancer
- •ii) Or any other cancer from which the subject has been disease-free for > 5 years
- •h) Uncontrolled diabetes (defined as Hgb A1C >or= 8.0%).
- •i) Unable to tolerate thromboembolic prophylaxis including, as clinically
- •indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
- •3) Physical and Laboratory Test Findings
- •a) Corrected serum calcium >or= 11.5 mg/dl within 2 weeks of randomization (despite appropriate measure such a short course of steroids, bisphosphonates, hydration, calcitonin)
- •b) Absolute neutrophil count < 1000 cells/mm3. No granulocyte colony stimulating factors (G-CSF or GM-CSF) allowed within 1 week of randomization. No pegylated granulocyte colony stimulating factors allowed within 3 weeks of randomization.
- •c) Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory
- •d) Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72
- •hours prior to qualifying laboratory value.
- •e) Total bilirubin >or= 2 x ULN , or direct bilirubin >or= 2.0 mg/dL f) AST or ALT >or= 3 x ULN
- •g) Creatinine clearance (CrCl) < 30 mL/min measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula
- •4) Prior Therapy or Surgery
- •a) Major surgery within 4 weeks prior to randomization as described in Section 3.4.4.
- •b) Administration of chemotherapy, biological, immunotherapy, or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to randomization (14 days for non-myelosu
研究者
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