EUCTR2013-000326-54-FR进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed 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
- 701
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. Adult male or female patients 18 years old and above with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria who have not received prior treatment for symptomatic multiple myeloma
- •2. Patients for whom lenalidomide and dexamethasone treatment is appropriate and who are not eligible for HDT-SCT for 1 or more of the following reasons:
- •* The patient is 65 years of age or older
- •* The patient is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCT
- •3. Patients must have measurable disease defined by at least 1 of the following 3 measurements:
- •* Serum M-protein = 1 g/dL (= 10 g/L)
- •* Urine M-protein = 200 mg/24 hours
- •* Serum free light chain assay: involved free light chain level = 10 mg/dL (= 100 mg/L), provided that the serum free light chain ratio is abnormal
- •4. Patients must meet the following clinical laboratory criteria:
- •* Absolute neutrophil count (ANC) = 1,000/mm3 and platelet count = 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days prior to randomization
- •* Total bilirubin = 1.5 × the upper limit of the normal range (ULN).
- •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × ULN.
- •* Calculated creatinine clearance = 30 mL/min
- •NOTE: Patients with a low creatinine clearance = 60 mL/min (or = 50 mL/min, according to local label/practice) will receive a reduced lenalidomide dose of 10 mg once daily on Days 1 through 21 of a 28-day cycle. The lenalidomide dose may be escalated to 15 mg once daily after 2 cycles if the patient is not responding to treatment and is tolerating the treatment. If renal function normalizes (ie, creatinine clearance > 60 mL/min or > 50 mL/min, according to local label/practice) and the patient continues to tolerate this treatment, lenalidomide may then be escalated to 25 mg once daily.
- •5. ECOG performance status of 0, 1, or 2.
- •6. Female patients who:
- •* Are postmenopausal for at least 24 months before the screening visit, OR
- •* Are surgically sterile, OR
- •* Females of childbearing potential (FCBP) must:
- •a. US and European Union (EU): Have TWO medically-supervised negative pregnancy tests (serum or urine with sensitivity of at least 25 mIU/mL), even if continuous abstinence is the chosen method of contraception. One test must be obtained within 10 to 14 days and the other test must be obtained within 24 hours prior to administering the first dose of the study drug regimen at Cycle 1, Day 1. The dates and results of pregnancy tests must be documented
- •c. Either agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR begin TWO reliable methods of birth control: 1 highly effective method and 1 additional effective method AT THE SAME TIME, at least 28 days before starting the study drug regimen through 90 days after the last dose of study treatment
- •d. Agree to ongoing pregnancy testing
- •e. Adhere to the guidelines of the The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other participants who are not using commercial supplies)
- •Male patients, even if surgically sterilized (ie, status postvasectomy), must:
- •* Agree to prac
排除标准
- •1. Prior treatment for multiple myeloma with either standard of care treatment or investigational regimen
- •NOTE: Prior treatment with corticosteroids or localized radiation is permitted as long as it is below a therapeutic level (maximum dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone over a 2-week period)
- •2. Radiotherapy within 14 days before randomization
- •3. Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
- •4. Inability or unwillingness to receive antithrombotic therapy
- •5. Female patients who are lactating and breastfeeding or have a positive pregnancy test during the screening period
- •6. Major surgery within 14 days before randomization.
- •NOTE: Kyphoplasty or vertebroplasty is not considered major surgery
- •7. Central nervous system involvement
- •8. Infection requiring IV antibiotic therapy or other serious infection within 14 days before randomization
- •9. Diagnosis of Waldenstrom’s macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
- •10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- •11. Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort within 14 days before randomization in the study
- •12. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
- •13. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).
- •14. Psychiatric illness/social situation that would limit compliance with study requirements
- •15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- •16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment
- •17. Treatment with any investigational products within 60 days before the first dose of the study drug regimen
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