Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma (BVD)

Inclusion Criteria:

• Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not necessarily at the time of relapse), according to International Myeloma Working Group criteria.
• Patient having received conventional chemotherapy in 1st line treatment because of age 65 years or over, or younger than 65 years and ineligible to high-dose therapy plus stem cell transplantation.
• Measurable disease (≥10g/L monoclonal gammapathy and/or ≥ 200 mg/24h proteinuria or involved serum free light chain ≥ 100mg/L with abnormal FLC ratio < 0.26 or > 1.65)
• Patient in 1st relapse or refractory to 1st line therapy. Relapse is defined by M-component increase of ≥25% from baseline, in serum and/or urine (the absolute increase in serum must be ≥ 5 g/l - the absolute increase of BJ proteins in urine must be ≥200 mg/24 h). (It is recommended to treat only symptomatic or rapidly evolutive relapses)
• Life expectancy of at least 3 months
• ECOG performance status <= 2 at study entry
• Laboratory test results within these ranges:
• Absolute neutrophil count >= 1.5 x 109/L
• Platelet count >= 100 x 109/L
• Serum creatinine <= 250 umol/l
• AST (SGOT) and ALT (SGPT) <= 3 x ULN
• Disease free of prior malignancies for >= 5 years, with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
• Able to adhere to the study visit schedule and other protocol requirements
• Using effective contraceptive methods during and for 6 months after study treatment (for fertile men, women of childbearing potential).
• Provision of informed consent.
• A period of at least 15 days must be respected between the last treatment of myeloma and the beginning of the study.

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Any comorbidity which places the subject at unacceptable risk if he/she were to participate in the study.
• Patients treated with high-dose therapy plus stem cell transplantation in 1st line therapy
• Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin)
• Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan
• Use of any other experimental drug or therapy within 28 days prior to the start of study treatment.
• Known hypersensitivity to the study drugs
• Positive HIV serology, positive hepatitis C serology, active infection hepatitis A, active infection hepatitis B.
• Severe cardiovascular disorders within 12 months prior to the start of study treatment (e.g. myocardial infarct, ischemic episodes, arrhythmias)
• Previous major surgery less than 30 days before start of treatment
• Active infection,
• Pregnant or lactating women.