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 VTD

Intergroupe Francophone du Myélome0 个研究点目标入组 200 人开始时间: 2008年3月12日最近更新: 2014年8月11日

适应症

试验速览

暂无简介。

•Newly diagnosed multiple myeloma (MM) patient
•- Adult under the age of 66
•- Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200mg/day)
•- Using effective contraceptive methods (for fertile men, women of childbearing potential)
•- Provision of informed consent
•- No evidence of active infection
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Asymptomatic MM (Multiple Myeloma)
•- Non-secretory MM.
•- Over the age of 65
•- 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 ?GT > 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

发起方

Intergroupe Francophone du Myélome