EUCTR2010-022445-20-GB进行中（未招募）1 期
A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated 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
- 862
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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 = 18 years or legal age of consent per local regulations.
- •b) ECOG performance status = 2.
- •c) Life-expectancy > 3 months.
- •d) Newly diagnosed, untreated, symptomatic, documented myeloma
- •i) Who are not candidates for high-dose therapy plus SCT because of age (= 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old, AND;
- •ii) Measureable disease (patient must meet one of these criteria)
- •(a) serum IgG M-protein = 0.5 g/dL OR
- •(b) serum IgA M-protein = 0.5 g/dL OR
- •(c) serum IgM M-protein = 0.5 g/dL OR
- •(d) serum IgD M-protein = 0.05 g/dL OR
- •(e) Urine M-protein = 200 mg/24-hour
- •3) Age and Reproductive Status
- •a) Women of childbearing potential (WOCBP) and men 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 120 days, men for up to 180 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP and also refer to the Revlimid risk management plan guidelines.
- •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) Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile; see Section 3.3.3 for the definition
- •of WOCBP) and men.
- •e) Sexually active fertile men must use effective birth control if their partners are WOCBP. 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 180 days after therapy.
- •f) Subjects must be willing to refrain from blood donations during study drug therapy and for 90 days after therapy.
- •4) Pharmacogenetic
- •To participate in the Pharmacogenetic Sample Amendment, subjects must provide a signed Pharmacogenetic Blood DNA informed consent.
- •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 189
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 673
排除标准
- •1) Target Disease Exceptions
- •a) Subjects with non-secretory or oligo-secretory or serum free lightchain only myeloma.
- •b) Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions.
- •c) Monoclonal Gammopathy of Undetermined Significance (MGUS) defined by all of the following: serum M protein < 3 g/dL, absence of
- •lytic bone lesions, anemia, hypercalcemia and renal insufficiency related to monoclonal protein and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
- •d) Diagnosis of Waldenstrom's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration
- •with lytic bone lesions.
- •e) 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) POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •b) 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.
- •c) Prior cerebrovascular event with persistent neurologic deficit.
- •d) Known HIV infection or active hepatitis A, B, or C.
- •e) Any medical conditions that, in the investigator's opinion, would impose excessive risk to the subject. Examples of such conditions
- •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.
- •f) 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.
- •g) Uncontrolled diabetes (defined as Hgb A1C >or= 8.0%).
- •h) Unable to tolerate thromboembolic prophylaxis including, aspirin, Coumadin (warfarin) or low-molecular weight heparin as clinically indicated.
- •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 value.
- •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 est
研究者
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