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

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.