Patients suffering from stage II/III (Salmon & Durie) relapsed or refractory multiple myeloma
Conditions
Interventions
Trade Name: Velcade
Product Name: Bortezomib
Product Code: PS-341
Pharmaceutical Form: Powder for injection
Trade Name: Ribomustin
Product Name: bendamustine
Product Code: CEP-18083
Pharmaceutical Fo
Sponsors
Wilhelminen Krebsforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the overall response rate to combination therapy of bortezomib plus bendamustine plus dexamethasone;Secondary Objective: to assess the progression-free survival, the overall survival, the time to maximum response and 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. | — |
Countries
Austria, Czech Republic
Outcome results
None listed