EUCTR2013-003113-17-PL进行中（未招募）1 期
An Open-Label, Phase 2 Study to Evaluate the Oral Combination ofMLN9708 With Cyclophosphamide and Dexamethasone In Patients WithNewly Diagnosed or Relapsed and/or Refractory Multiple MyelomaRequiring Systemic Treatment
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
- 148
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 of age or older with a confirmed diagnosis of symptomatic MM according to standard criteria
- •2. Patients for whom cyclophosphamide and dexamethasone treatment is appropriate and who are considered 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. Adult male or female patients 18 years or older with a confirmed diagnosis of symptomatic MM either currently or at the time of initial diagnosis, according to standard criteria, and relapsed and/or refractory
- •disease after 1 to 3 lines of prior therapy. A patient is considered to have refractory disease if disease progression occurred during the treatment
- •period or within 60 days of receiving the last dose of a given therapy. A line of therapy is defined as 1 or more cycles of a single-agent or combination therapy or a sequence of planned treatments such as
- •induction therapy followed by autologous stem cell transplantation (ASCT) and then maintenance therapy.
- •4. No evidence of graft-versus-host disease for patients who have undergone prior allogeneic stem cell transplantation.
- •NDMM and RRM:
- •5. 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.
- •6. Patients must meet all of the following clinical laboratory criteria:
- •* Absolute neutrophil count (ANC) = 1000/mm3 and platelet count =
- •75,000/mm3. Platelet transfusions to help patients meet eligibility
- •criteria are not allowed within 3 days prior to administration of the study drug
- •* Total bilirubin = 1.5 x the upper limit of the normal range (ULN)
- •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •* Calculated creatinine clearance (CrCL) = 30 mL/min
- •7. Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- •8. Female patients who:
- •* Are postmenopausal for at least 1 year before the screening visit, or
- •* Are surgically sterile, or
- •* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or
- •* Agree to practice true abstinence over the period previously described, when this is in line with the preferred and usual lifestyle of the subject.
- •(Periodic abstinence (eg, calendar, ovulation, symptothermal,postovulation methods] and withdrawal are not acceptable methods of
- •contraception.), and
- •* Adhere to any treatment-specific pregnancy prevention guidelines for
- •Cyclophosphamide and dexamethasone
- •Male patients, even if surgically sterilized (ie, status postvasectomy),
- •* Agree to practice effective barrier contraception during the entire
- •study treatment period and through 90 days after the last dose of study
- •* Agree to practice true abstinence over the period previously described,
- •when this is in line with the preferred and usual lifestyle of the subject.
- •(Periodic abstinence [eg, calendar, ovulation, symptothermal,
- •postovulation methods for the f
排除标准
- •1. Prior treatment for multiple myeloma with either standard of care
- •treatment or investigational regimen (for patients with NDMM only).
- •NOTE: Prior treatment with corticosteroids (maximum dose of
- •corticosteroids should not exceed the equivalent of 160 mg of
- •dexamethasone over 14 days. Localized radiation is permitted as long as
- •it is below a therapeutic level and administered at least 14 days prior to
- •the first dose of study treatment.
- •2. Diagnosis of smoldering MM, Waldenström's macroglobulinemia,
- •POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal
- •gammopathy, and skin changes) syndrome, plasma cell leukemia,
- •primary amyloidosis, myelodysplastic syndrome, or myeloproliferative
- •3. Central nervous system involvement.
- •4. Diagnosed or treated for another malignancy within 2 years before the
- •first dose 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.
- •5. Peripheral neuropathy Grade 1 with pain or Grade 2 or higher
- •peripheral neuropathy of any cause on clinical examination during the
- •Screening period.
- •6. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drug, including difficulty swallowing.
- •7. Infection requiring IV antibiotic therapy or other serious infection
- •within 14 days before the first dose of study drug.
- •8. Ongoing or active infection, known human immunodeficiency virus
- •(HIV) positive, active hepatitis B or C infection
- •9. 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 the first dose of study treatment.
- •10. Known allergy to any of the study medications, their analogues, or
- •excipients in the various formulations.
- •11. Major surgery within 14 days before the first dose of study drug.
- •(Note: kyphoplasty or vertebroplasty is not considered major surgery.)
- •12. Female patients who are lactating and breastfeeding or have a
- •positive serum pregnancy test during the Screening period.
- •13. Any serious medical or psychiatric illness that could, in the
- •investigator's opinion, potentially interfere with the completion of
- •treatment according to this protocol.
- •14. 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.
- •15. Treatment with any investigational products for reasons other than
- •MM within 30 days before the first dose of study drug.
研究者
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