NCT00910897Unknown3 期
A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 205
- 试验地点
- 56
研究概览
简要总结
Primary objective:
- Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.
Secondary objectives:
-
Compare the following parameters following 4 cycles of VD or VTD induction treatment:
-
CR rate+ very good partial remission (VGPR) rate
-
Overall remission rate (CR + VGPR + partial remission (PR) rate)
-
K/l light chain ratio in patients in CR.
-
Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
-
Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed symptomatic multiple myeloma (MM) patient
- •Aged under 65
- •Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
- •Using effective contraceptive methods (for fertile men, women of childbearing potential)
- •Provision of informed consent
- •No evidence of active infection
排除标准
- •Asymptomatic MM
- •Non-secretory MM
- •Aged 66 years or over
- •ECOG performance status over 2 (see Appendix 2)
- •Proven amyloidosis
- •A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
- •Positive HIV serology
- •A personal medical history of severe psychiatric disease
- •Severe diabetes contraindicating the use of high-dose dexamethasone
- •NCI grade ³ 2 peripheral neuropathy
- •Serum clinical chemistry:
- •creatinine level > 300 µmol/L or requiring dialysis
- •bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL)
- •Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
- •Radiation therapy in the 2 weeks preceding randomization
- •A personal medical history of allergic reactions to compounds containing boron or mannitol
- •Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure
- •Use of any investigational drug in the 30 days preceding randomization
- •Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
- •Severe pulmonary troubles (including acute infiltrative pneumopathy)
研究组 & 干预措施
Velcade-Dexamethasone
Active Comparator
干预措施: Velcade-Dexamethasone (Drug)
Velcade-Thalidomide-Dexamethasone
Active Comparator
干预措施: Velcade-Thalidomide-Dexamethasone (Drug)
研究者
研究点 (56)
Loading locations...
相似试验
进行中（未招募）
不适用
A PHASE III STUDY OF VELCADE (BORTEZOMIB) DEXAMETHASONE (VD) VERSUS VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA. - VD vesus VTDPATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA, UNDER THE AGE OF 66, CANDIDATE FOR AUTOLOGOUS STEM CELL TRANSPLANTATIONMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2007-005204-40-FRIntergroupe Francophone du Myélome200
进行中（未招募）
不适用
A PHASE III STUDY OF VELCADE (BORTEZOMIB)-DEXAMETHASONE (VD) VERSUS VELCADE (BORTEZOMIB)-THALIDOMIDE-DEXAMETHASONE (VTD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA - VD versus VTDPATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA, UNDER THE AGE OF 66, CANDIDATE FOR AUTOLOGOUS STEM CELL TRANSPLANTATIONMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2007-005204-40-BEIntergroupe Francophone du Myélome200
已完成
1 期
Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma PatientsMultiple MyelomaNCT00507442Millennium Pharmaceuticals, Inc.158
进行中（未招募）
不适用
PHASE II STUDY ON TREATMENT WITH VELCADE, DEXAMETHASONE AND FOTEMUSTINE IN PATIENTS AFFECTED BY RELAPSED/REFRACTORY MULTIPLE MYELOMA - B-MUDRelapsed/refractory Multiple MyelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2009-011838-10-ITOSPEDALE POLICLINICO S. MATTEO
已完成
2 期
Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms MacroglobulinemiaWaldenstrom's MacroglobulinemiaNCT00250926Dana-Farber Cancer Institute23