NCT00305812已完成2 期
A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 14
- 主要终点
- Incidence of dose-limiting toxicity within first 3 courses of treatment
研究概览
简要总结
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with melphalan may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation.
Secondary
- Characterize the toxicity profile of lenalidomide in combination with melphalan.
- Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone.
- Determine progression-free and overall survival of these patients.
- Determine time to dose modification and time to dose discontinuation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed multiple myeloma by one of the following:
- •Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
- •Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis
- •Bone marrow < 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria
- •Ineligible for stem cell transplantation due to any of the following:
- •Advanced age
- •Comorbid illness
- •Patient preference
- •Previously untreated disease
- •Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis
- •No nonsecretory myeloma
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 150,000/mm^3
- •Creatinine ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •AST and/or ALT ≤ 1.5 times ULN
- •Alkaline phosphatase ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment
- •No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix
- •No hypersensitivity to thalidomide or its components, including the development of a desquamating rash
- •No other serious illness or medical condition that would preclude study participation
- •No history of significant neurologic or psychiatric disorder that would preclude informed consent
- •No known HIV positivity
- •No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:
- •Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization
- •Any cardiac disease that increases risk for ventricular arrhythmia
- •History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following:
- •Multifocal premature ventricular contractions
- •Trigeminy
- •Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or corticosteroids for the treatment of multiple myeloma
- •Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,< 120 mg for dexamethasone or < 792 mg for prednisone)
- •Prior radiotherapy to single sites for pain control or local plasmacytoma allowed
- •Prior or concurrent bisphosphonates allowed
- •At least 28 days since prior investigational anticancer agents or therapy
- •No concurrent corticosteroids above physiologic replacement doses
- •Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed
- •No concurrent filgrastim (G-CSF) on day 1 of course 1
- •No other concurrent anticancer therapy
- •No other concurrent investigational therapy
排除标准
- 未提供
结局指标
主要结局
Incidence of dose-limiting toxicity within first 3 courses of treatment
次要结局
- Overall survival
- Time to progression
- Toxicity
- Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy
- Duration of disease-free interval
- Time to dose modification
- Time to dose discontinuation
研究者
研究点 (14)
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