PHASE II MULTICENTER CLINICAL TRIAL TO INVESTIGATE THE EFFICACY ANDSAFETY OF BENDAMUSTINE, DEXAMETHASONE AND THALIDOMIDE INRELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER TREATMENTWITH LENALIDOMIDE AND BORTEZOMIB OR WHICH ARE INELIGIBLE TO ONE OFTHESE DRUGS.

AZIENDA SANITARIA DELL'ALTO ADIGE - COMPRENSORIO SANITARIO DI BOLZANO0 个研究点目标入组 30 人开始时间: 2012年3月14日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•Relapsed or refractory active MM after treatments containing bortezomib and lenalidomide or
•ineligible to one of these drugs.
•Age 18 years.
•All previous multiple myeloma treatments, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this
•study, except corticosteroids therapy.
•ECOG performance status <2 at study entry, unless it is due to MM.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Patients with contraindications for treatment with bendamustine, dexamethasone and
•thalidomide.
•Uncontrolled or severe cardiovascular disease.
•Known hypersensitivity to thalidomide or purine analogues
•Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
•Peripheral neuropathy grade =2 according to WHO
•Known positive for HIV or infectious hepatitis, type A, B or C.
•Pregnant or breast feeding females.

发起方

AZIENDA SANITARIA DELL'ALTO ADIGE - COMPRENSORIO SANITARIO DI BOLZANO