A double randomized phase III study in patients with newly diagnosed multiple myeloma to compare progression free survival (PFS) following treatment with either Bortezomib, Melphalan, Prednisone (VMP) or High Dose Melphalan followed by either Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation or no consolidation treatment, and Lenalidomide maintenance.

HOVO0 个研究点目标入组 1,500 人开始时间: 2012年4月13日最近更新: 2020年1月13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)
•-Measurable disease as defined by the presence of M-protein in serum or urine (serum Mprotein > 10 g/l or urine M-protein > 200 mg/24 hours), or abnormal free light chain ratio;
•-Age 18-65 years inclusive;
•-World Health Organisation (WHO) performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions)
•-Negative pregnancy test at inclusion if applicable;
•-Written informed consent.
•Randomization 1
•-WHO performance 0-2;
•-Bilirubin and transaminases < 2.5 times the upper limit of normal values;
•-A suitable stem cell graft containing at least 4 x 10^6 CD34+ cells/kg (or according to national guidelines).
•Randomization 2
•-Bilirubin and transaminases < 2.5 times the upper limit of normal values;
•-Absolute Neutrophil Count >= 0.5 x 10^9/l and platelets > 20 x 10^9/l;
•-Patient is able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.

•Known intolerance of Boron;
•-Systemic light chain (AL) amyloidosis;
•-Primary Plasmacell Leukemia;
•-Non-secretory multiple myeloma (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);
•-Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
•-Patients with glomerular filtration rate (GFR) <15 ml/min,
•-Patients known to be Human immunodeficiency virus (HIV)-positive;
•-Patients with active, uncontrolled infections;
•-Patients with neuropathy, Common Toxicity Criteria for Adverse Events (CTCAE) 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.
•Randomization 1
•-Severe pulmonary, neurologic, or psychiatric disease;
•CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;
•-Allogeneic Stem Cell Transplantation (Allo SCT) planned;
•-Progressive disease.
•Randomization 2
•-Progressive disease;
•-Neuropathy, except CTCAE grade 1;
•-CTCAE grade 3-4 polyneuropathy during Bortezomib treatment

发起方

HOVO