EUCTR2010-022445-20-ES进行中（未招募）1 期
A Phase 3, Randomized, Open Label Trial ofLenalidomide/dexamethasone With or Without Elotuzumab in Subjectswith Previously Untreated 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
- 748
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- •care, with the understanding that consent may be withdrawn by the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) Newly diagnosed ,untreated, symptomatic, documented myeloma
- •i) Who are not candidates for high-dose therapy plus SCT because of
- •age (>or= 65 years) or coexisting conditions AND;
- •ii) Measureable disease: serum IgG, IgA, IgM M-protein >or= 0.5 g/dL
- •or serum IgD M-protein >or= 0.05 g/dL or >or= 200 mg urinary Mprotein
- •excretion /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 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
- •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 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 90 days after therapy.
- •f) Subjects must be willing to refrain from blood donations during study
- •drug therapy and for 8 weeks after therapy.
- •4) To participate in this Pharmacogenetic Sample Amendment, subjects
- •must provide a signed Pharmacogenetic Blood DNA informed consent
- •and must have consented to participate in the main clinical trial
- •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.
- •2) Medical History and Concurrent Diseases
- •a) Known or suspected cardiac amyloidosis; 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 history of, or documented positive hepatitis B or C or HIV infection.
- •e) 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 of Hepatitis A or that requires parenteral antiinfective 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) Cervical carcinoma in situ;
- •iii) Adequately treated Stage I or II cancer from which the subject is currently in complete remission;
- •iv) Or any other cancer from which the subject has been disease-free for g) Uncontrolled diabetes.
- •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= 14 mg/dl within 2 weeks of randomization.
- •b) Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within 1 week of randomization.
- •c) Platelets < 75,000 cell/mm3 (75 x 10E9/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, and 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) Administration of systemic chemotherapy, biological, immunotherapy, clarithromycin
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