A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma - HOVON 95 MM

HOVON Foundation0 个研究点目标入组 1,500 人开始时间: 2013年10月2日最近更新: 2013年11月26日

适应症

试验速览

暂无简介。

•- Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS (see appendix A), i.e. at least one of the CRAB criteria should be present;
•- Age 18-65 years inclusive;
•- WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions)
•- Negative pregnancy test at inclusion if applicable;
•- Written informed consent.
•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 1500
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Known intolerance of Boron;
•- Systemic AL amyloidosis;
•- Primary Plasmacell Leukemia;
•- Non-secretory MM;
•- Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control;
•- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E);
•- Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
•- Patients with GFR <15 ml/min,
•- Patients known to be HIV-positive;
•- Patients with active, uncontrolled infections;
•- Patients with neuropathy, CTC grade 2 or higher;
•- Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
•- Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
•-Lactating women;

发起方

HOVON Foundation