UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
详细描述
Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation, and maintenance. Induction is designed to induce (or bring about) myeloma into remission. Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide. Some patients may be eligible to receive the transplant as an outpatient, based on general health and other factors.After recovery from the transplant phase of the study (approximately 6 weeks), patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment. All patients will receive post-transplant consolidation treatment, which in earlier studies has been found to be helpful in maintaining patients response after transplant. Therefore, all patients will receive a combination of drugs called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide. If you are also taking thalidomide, you will continue taking it throughout, and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks, and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete, you will begin the last phase of the study, which is maintenance. Maintenance is designed to keep your myeloma in remission long-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have newly diagnosed active multiple myeloma requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
- •Protein criteria must be present in order to evaluate response.Non-secretory patients are eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focal plasmacytomas on MRI or diffuse hyperintense signal on STIR images in the absence of hematopoietic growth factors is seen.
- •All necessary baseline studies for determining stage, bloodwork, and bone marrow must be obtained within 35 days prior to registration.
- •Patients must have received no more than one cycle of prior chemotherapy including one month of Dexamethasone and Thalidomide for this disease. Patients may have received prior radiotherapy provided approval has been obtained by one of the study coordinators.
- •Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
- •Patients with renal failure, even if on dialysis, are eligible if it is felt to be due to myeloma and if the duration of renal failure does not exceed two months
- •Patients must be 75 years of age or less at the time of registration
- •All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- •If medically appropriate, patients with pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath should have these conditions attended to prior to registration.
排除标准
- •Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection
- •Patients must not have uncontrolled diabetes
- •Patients with recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO or MUGA should be within the institutional normal range and must be performed within 42 days prior to registration.
- •Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease.
- •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval and there must be no prior treatment with cytotoxic drugs that could potentially be assigned on this treatment protocol.
- •Pregnant or nursing women may not participate. Women of child-bearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method.
研究组 & 干预措施
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Thalidomide (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Ara-C (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: BCNU (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Cisplatin (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Cytoxan (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Dexamethasone (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Etoposide (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Filgrastim (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Recombinant GM-CSF (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Interferon-alpha-2b (Drug)
Thalidomide
Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance
干预措施: Melphalan (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Ara-C (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: BCNU (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Cisplatin (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Cytoxan (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Dexamethasone (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Doxorubicin (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Etoposide (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Filgrastim (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Recombinant GM-CSF (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Interferon-alpha-2b (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Melphalan (Drug)
No Thalidomide
During induction, consolidation, and maintenance steps patient receives no thalidamide
干预措施: Vincristine (Drug)
结局指标
主要结局
Overall Survival
时间窗: 6 Years
Overall Survival at six years after initiating protocol therapy
次要结局
未报告次要终点