NL-OMON50624已完成3 期
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
HOVO0 个研究点目标入组 500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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 plasmocytoma by
- •biopsy, - Written informed consent
排除标准
- •- 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 , -
研究者
相似试验
进行中（未招募）
1 期
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) follwed by maintenance with Lenalidomide.Multiple MyelomaEUCTR2007-004007-34-SEHOVON Foundation668
进行中（未招募）
1 期
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 MMMedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple MyelomaEUCTR2007-004007-34-DKHOVON Foundation668
进行中（未招募）
1 期
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 lenalidomideMedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864Multiple MyelomaEUCTR2007-004007-34-NLHOVON Foundation668
进行中（未招募）
1 期
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 lenalidomideMultiple MyelomaEUCTR2007-004007-34-BEHOVON Foundation668
已完成
不适用
Randomised phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus PrednisoneMultiple myeloma and malignant plasma cell neoplasmsCancerMultiple MyelomaISRCTN90692740Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)420