EUCTR2010-019820-30-GR进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination with Low-Dose Dexamethasone versus High-Dose Dexamethasone in Subjects with Refractory or Relapsed and Refractory Multiple Myeloma - Nimbus
Celgene Corporation0 个研究点目标入组 426 人开始时间: 2011年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 426
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. Must be = 18 years at the time of signing the informed consent form.
- •2. The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. The only exception is if a skeletal survey was performed within 60 days prior to the start of Cycle 1, a new survey will not be required.
- •3. Must be able to adhere to the study visit schedule and other protocol requirements.
- •4. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein = 1.0 g/dL or urine M-protein = 200 mg/24 hours). However, for subjects with IgA multiple myeloma, a serum M-protein of = 0.5 g/dL or urine M-protein = 200 mg/24 hours will be eligible for the study.
- •5. Subjects must have undergone prior treatment with = 2 treatment lines of anti-myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line.
- •6. Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy.
- •Primary refractory: Subjects who have never achieved any response better than PD to any previous line of anti-myeloma therapy.
- •Relapsed and refractory: Subjects who have relapsed after having achieved at least stable disease for at least two cycles of treatment to at least one prior regimen and then developed PD on or within 60 days of completing their last myeloma therapy.
- •7. All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib, either alone or in combination regimens as follows in criterion # 8.
- •8. Medical records must be available that provide documentation of the following criteria for refractoriness that make the subject eligible for the study:
- •All subjects must have failed treatment with both lenalidomide and bortezomib as follows:
- •- Documented PD during or within 60 days of completing treatment with lenalidomide and/or bortezomib, or
- •- In case of prior response (= PR) to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or
- •- Subjects who have not had a = MR response and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or bortezomib-containing regimen:
- •Bortezomib-containing regimen: a toxicity such as > grade 2 peripheral neuropathy or = grade 2 painful neuropathy. Peripheral neuropathy must resolve to grade 1 prior to study entry.
- •Lenalidomide-containing regimen: a toxicity which led to permanent discontinuation of lenalidomide, such as grade 4 rash. Rash must resolve to = Grade 1 prior to study entry.
- •Patients must have received adequate prior alkylator therapy either as part of ASCT or a minimum of 6 cycles of an alkylator based therapy.
- •9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- •10. Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 28 days after discontinuation from the study drug and must agree to regular pregnancy testing during this timeframe.
- •11. Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
- •12. Males must agree to use a latex condom during any s
排除标准
- •1. Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,000/µL
- •Platelet count < 75,000/ µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/ µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells
- •Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula (See Appendix L)
- •Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L); or free ionized calcium > 6.5 mg/dL (> 1.6 mmol/L)
- •Hemoglobin = 8 g/dL (= 4.96 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
- •Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •Serum total bilirubin > 2.0 mg/dL
- •2. Prior history of malignancies, other than MM, unless the subject has been free of the disease for = 3 years. Exceptions include the following:
- •Basal or Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix or breast
- •Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •3. Previous therapy with Pomalidomide.
- •4. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone.
- •5. Resistance to high-dose dexamethasone used in the last line of therapy: Defined as disease progression on or within 60 days of receiving the last dose of high-dose dexamethasone used in the last line of therapy, either as single agent or in combination. Subjects who progressed on low-dose dexamethasone will qualify for the trial.
- •6. Peripheral neuropathy = Grade 2.
- •7. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
- •8. Subjects who are planning for or who are eligible for stem cell transplant.
- •9. Subjects with any one of the following:
- •Congestive heart failure (NY Heart Association Class III or IV)
- •Myocardial infarction within 12 months prior to starting study treatment
- •Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- •10. Subjects who received any of the following within the last 14 days of initiation of study treatment:
- •Plasmapheresis
- •Major surgery (kyphoplasty is not considered major surgery)
- •Radiation therapy
- •Use of any anti-myeloma drug therapy
- •11. Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.
- •12. Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment.
- •13. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •14. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
- •15. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study.
- •16. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form.
- •17. Pregnant or breastfeeding females.
- •18. Known HIV positivity or active infectious hepatitis A, B or C.
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