Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide - HOVON 87 MM/NMSG 18

HOVON Foundation0 个研究点目标入组 668 人开始时间: 2009年9月14日最近更新: 2020年8月10日

适应症

试验速览

暂无简介。

•- Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria
•- Age > 65 years or patients = 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation
•- WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients =75 years
•- Measurable disease as defined by the presence of M-protein in serum or urine or proven plasmacytoma by biopsy
•- 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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 658

•- Non-secretory MM
•- Known hypersensitivity to thalidomide
•- Systemic AL amyloidosis
•- Polyneuropathy, grade 2 or higher
•- Severe cardiac dysfunction (NYHA classification II-IV)
•- Severe pulmonary dysfunction
•- Significant hepatic dysfunction (total bilirubin =30 umol/l or transaminases =3 times normal level), unless related to myeloma
•- Creatinine clearance < 30 ml/min
•- Patients with active, uncontrolled infections
•- Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed.
•- Patients known to be HIV-positive
•- History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
•- Not able and/or not willing to use adequate contraception
•- Pregnancy

发起方

HOVON Foundation