Clinical trial NCT01045681 (phase 2, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: bendamustine, velcade and dexamethasone
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        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.