EUCTR2012-000750-66-IE进行中（未招募）1 期
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma - ECOG E3A06
ICORG-the All Ireland Co-operative Oncology Research Group0 个研究点目标入组 40 人开始时间: 2012年9月6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
- 40
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
- •- Age = 18 years.
- •- Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following: 1) Bone marrow plasmacytosis or
- •2) Abnormal serum free light chain ratio
- •- Patients must have measurable levels of monoclonal protein (M-protein): =1g/dL on serum protein electrophoresis or =200 mg of monoclonal protein on a 24 hour urine protein electrophoresis
- •- Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., > 11 mg/dL).
- •- The following laboratory levels must be obtained within four weeks prior to randomization:
- •Hemoglobin = 11 g/dL / Platelet count = 100,000 cells/mm3 / Absolute neutrophil count = 1500 cells/mm3 / Calculated creatinine clearance = 30 mL/min / Bilirubin = 1.5 mg/dL / SGPT (ALT) and SGOT (AST) = 2.5 times the upper limit of normal.
- •- Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day.
- •- Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
- •- ECOG performance status 0, 1, or 2.
- •- Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
- •- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer.
- •- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
- •- HIV infection is not excluded. HIV+ patients must meet the following criteria:
- •* CD4 cell count > 350/mm3
- •* No history of AIDS-related illness
- •* Not currently prescribed zidvoudine or stavudine
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- No prior or concurrent systemic or radiation therapy for the treatment of myeloma.
- •- Concurrent use of bisphosphonates is not permitted. However, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted.
- •- Prior or concurrent use of erythropoietin is disallowed.
- •- Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
- •- Patients must not have active, uncontrolled seizure disorder. Patients must have had no seizures in the last 6 months.
- •- Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome.
- •- Patients must not have baseline bone lesions or plasmacytomas.
- •- Patients with monoclonal gammopathy of undetermined significance are not eligible.
- •- Patients must not have Grade 2 or higher peripheral neuropathy.
- •- Patients must not have active, uncontrolled infection.
- •- Patients should not have New York Heart Association classification III or IV heart failure.
- •- Patients should not be felt to have an immediate need for chemotherapy.
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