NL-OMON55577已完成3 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 Relapsed and/or Refractory Multiple Myeloma - Millennium C16010
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Multiple myeloma diagnosed according to standard criteria either
- •currently or at the time of initial diagnosis.
- •2.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.
- •3.Patients with relapsed and/or refractory MM who have received 1 to 3
- •prior therapies.
- •4.ECOG performance status of 0, 1, or 2.
排除标准
- •1. Patient was refractory to lenalidomide or proteasome inhibitor-based therapy
- •at any line.
- •2. Female patients who are lactating or pregnant.
- •3. Failure to have fully recovered (ie, < Grade 1 toxicity) from the effects
- •of prior chemotherapy regardless of the interval since last treatment.
- •4. Major surgery within 14 days before randomization.
- •5. Radiotherapy within 14 days before randomization.
- •6. Central nervous system involvement.
- •7. Infection requiring systemic antibiotic therapy or other serious infection
- •within 14 days before randomization.
- •8. 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.
- •9. 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.
- •10. 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.
- •11. Ongoing or active systemic infection, active hepatitis B virus infect,
- •active hepatitis C infection, or known human immunodeficiency virus (HIV)
- •12. 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.
- •13. Psychiatric illness/social situation that would limit compliance with study
- •requirements.
研究者
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