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 VTD

Intergroupe Francophone du Myélome0 个研究点目标入组 200 人开始时间: 2007年12月3日最近更新: 2012年3月19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 (>or= to 10 g/L) or the urine (>or= 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