NCT00028886Unknown3 期
A Randomized Phase III Study On The Effect Of Thalidomide Combined With Adriamycin, Dexamethasone (AD) And High Dose Melphalan In Patients With Multiple Myeloma
Commissie Voor Klinisch Toegepast Onderzoek34 个研究点 分布在 2 个国家目标入组 450 人开始时间: 2001年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
- 试验地点
- 34
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
- Compare the efficacy of doxorubicin, dexamethasone, and high-dose melphalan with versus without thalidomide, in terms of event-free survival, of patients with multiple myeloma.
- Determine the response rate, complete response rate, overall survival, and progression-free survival of patients treated with these regimens.
- Determine the safety and toxicity of thalidomide in combination with intensive chemotherapy in these patients.
- Assess the value of prognostic factors at diagnosis in individual patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and treatment policy (1 course vs 2 courses of high-dose melphalan). Patients are randomized to 1 of 2 treatment arms.
Arm I:
- Patients receive induction chemotherapy (AD) comprising doxorubicin IV on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients receive oral thalidomide daily beginning on day 1 and continuing until 2 weeks before start of stem cell mobilization. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Patients receive stem cell mobilization with chemotherapy comprising cyclophosphamide IV on day 1 and doxorubicin IV and oral dexamethasone on days 1-4 (CAD). Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until last apheresis.
- Beginning 8-10 weeks after stem cell collection, patients receive low-dose oral thalidomide daily and high-dose melphalan IV on days -3 and -2 as intensification. Patients undergo stem cell infusion on day 0. Patients may receive a second course of high-dose melphalan 2-3 months after the first course, in which case, stem cell infusion follows the second course of melphalan.
- Patients receive maintenance therapy with oral thalidomide daily until disease progression or after 3 months if no response.
- Beginning 2 months after the last course, patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 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
- •Stage II or III
- •No systemic amyloid light-chain amyloidosis
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No significant hepatic dysfunction*
- •Bilirubin less than 1.75 mg/dL*
- •AST/ALT less than 2.5 times normal* NOTE: *Unless related to myeloma
- •Not specified
- •Cardiovascular:
- •No severe cardiac dysfunction
- •No New York Heart Association class II, III, or IV heart disease
- •HIV negative
- •No active uncontrolled infection
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No known intolerance to thalidomide
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Patients 18 to 55 years of age must not have been allocated before study randomization to allogeneic stem cell transplantation with an HLA-identical sibling donor
- •Chemotherapy:
- •No more than 2 prior courses of melphalan and prednisone therapy for local myeloma progression
- •No other prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior local radiotherapy for local myeloma progression allowed
- •No other prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Event-free survival
次要结局
- Overall survival
- Partial response and complete response
- Toxicity
- Progression-free survival
研究者
研究点 (34)
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