JPRN-jRCT2080221780已完成1 期
A Phase 1 Study of MLN9708 in Japanese Patients with Relapsed and/or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
Ixazomib at a dose of 4.0 mg as a single agent or in combination with standard dose of Rd is safe and tolerable in Japanese patients with RRMM. The data reported in this final CSR addendum do not materially change the results of the primary CSR and offer insights into the long-term efficacy and safety of ixazomib
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Japanese participants with multiple myeloma according to diagnostic criteria.
- •2) Previously treated with 2 or more regimens including all the following drugs; bortezomib, thalidomide or lenalidomide, corticosteroids
- •3) participants who have relapsed following the previous therapy or failed to continue the treatment due to their intolerability to the last treatment regimen for myeloma
- •4) Measurable disease defined by at least one 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 (FLC) assay: involved FLC level >= 10 mg/dL (>= 100 mg/L), provided that the serum FLC ratio is abnormal.
- •5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- •6) participants 20 years or older at giving their informed consent.
- •7) participants must be able to stay in the hospital for Cycle 1 treatment.
- •8) Participants must meet the following laboratory criteria at screening; Absolute neutrophil count (ANC): >= 1,000/mm^3, Platelet count: >= 75,000/mm^3, Total bilirubin: <=1.5 x the upper limit of normal range (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): <= 3 x ULN, Creatinine clearance: calculated by using Cockcroft-Gault formula ; MLN9708 monotherapy cohort: >= 30 mL/min; MLN9708 with Rd cohort: >= 60 mL/minA
- •9) participants recovered (Grade 1) from the toxicities of the prior treatments. ANC >= 1,000/mm^3.
- •10) Life expectancy of at least 3 months, in the judgment of the investigator.
- •11) participants conforming to proper management guidelines of lenalidomide (MLN9708 with Rd cohort only).
排除标准
- •1) Participants with plasmacytoma only.
- •2) Participants with plasma cell leukemia.
- •3) Participants with central nervous system invasion.
- •4) Radiotherapy within 14 days before enrollment.
- •5) Other anti-tumor drug administration within 21 days before enrollment.
- •6) Other investigational products administration within 21 days before enrollment (60 days from the last dose for carfilzomib).
- •7) Antibody treatment within 42 days before enrollment.
- •8) Systemic treatment with potent CYP1A2 inhibitors (fluvoxamine, enoxacin), potent CYP3A inhibitors (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole), or potent CYP3A inducers (rifampin, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of foods containing Ginkgo biloba extract, St. John's Wort, or grapefruit within 14 days before enrollment.
- •9) Treatment with corticosteroids greater than 10 mg of prednisolone per day. Inhaled and topical steroids are permitted.
- •10) Peripheral neuropathy >= Grade 2
- •11) Diarrhea >= Grade 2
- •12) Major surgery requiring general anesthesia within 14 days before enrollment
- •13) Infection requiring systemic antibiotic treatment or other serious infections within 14 days before enrollment
- •14) Evidence of concurrent uncontrolled cardiovascular conditions including hypertension, cardiac arrhythmias, New York Heart Association (NYHA) Class III or worse congestive heart failure, angina, myocardial infarction, or cerebral infarction within 6 months before enrollment.
- •15) QTc > 470 milliseconds on a 12-lead ECG obtained during the screening period
- •16) Tested positive for human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBs antigen), or hepatitis C virus (HCV) antibody during the screening period
- •17) Hypersensitivity to MLN9708 (including excipients), boron, or boron-containing drugs
- •18) Hypersensitivity to lenalidomide, or dexamethasone, or excipients contained in the formulation of each drug (MLN9708 with Rd cohort only)
- •19) Known gastrointestinal diseases (difficulty swallowing, inflamed gastroenteritis, and Crohn disease), or gastrointestinal procedure (endoscopic procedure is permitted), that could interfere with the oral absorption or tolerance of the study treatment
- •20) Uncontrolled diabetes mellitus
- •21) A history of interstitial lung disease or lung fibrosis, or a current complication of interstitial lung disease or lung fibrosis diagnosed by chest imaging.
- •22) Prior or current complications of deep vein thrombosis or pulmonary embolism (MLN9708 with Rd cohort only)
- •23) Diagnosed or treated for another malignancy within 2 years before the first dose of MLN9708 or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have complete resection.
- •24) Participants who do not consent to use adequate contraceptive precautions (e.g. condoms and oral contraceptives) during the following term:
- •- For women with childbearing potential, from when giving their consent through 3 months after the last dose of MLN9708, dexamethasone, or lenalidomide
- •- For men having their partners with childbearing potential, from when giving their consent through 4 months after the last dose of MLN9708,
- •dexamethasone, or lenalidomide
- •25) Pregnant (e.g. positive for pregnancy test) or lactating. Lactation is prohibited from the first dose through 6 weeks after the last dose of MLN9708, dexamethasone, and lenalidom
研究者
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