Multicenter Phase II Study:Bendamustine plus Bortezomib plus Dexamethasone in the treatment of stage II/III relapsed or refractory multiple myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

•Age at leaset 18 years at the time of signing the informed consent form
•Life expectancy of at least 3 month
•Able to adhere to the study visit schedule and other protocol requirements
•Relapsed or refractory MM in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria)
•All previous cancer therapy, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroid therapy.
•ECOG performance status of minimum 2 at study entry
•Laboratory test results within these ranges:
-Absolute neutrophil count minimum 1.5 x 109/L
-Platelet count minimum 100 x 109/L
-Total bilirubin not more than 1.5 mg/dL
-AST (SGOT) and ALT (SGPT) not more than 2 x ULN or not more than 5 x ULN if hepatic lesions are present.
•Disease free of prior malignancies for minimum of 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
•Fertile patients must use effective contraception during and for 6 months after study treatment

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
•Pregnant or breast feeding females
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by NCI CTCAE, version 3.0.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Known hypersensitivity to the study drugs
•Any prior use of bortezomib or bendamustine in the last six months
•Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan
•Known positive for HIV or infectious hepatitis, type A, B or C.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the overall response rate to combination therapy of bortezomib plus bendamustine plus dexamethasone;Secondary Objective: to assess <br>the progression-free survival,<br>the overall survival, <br>the time to maximum response and <br>the toxicity;Primary end point(s): The present trial is designed as a phase II study which aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory MM. The response rate, i.e. the rate of patients achieving a CR or PR as defined by the International Myeloma Working Group uniform response criteria, divided by the total intent-to-treat patient number is chosen as primary efficacy endpoint.

Secondary Outcome Measures

Name	Time	Method

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