Clinical trial NCT01190787 (phase 2, status: active, not recruiting)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: velcade subcutaneous melphalan prednisone, velcade cyclophosphamide prednisone, velcade prednisone
SMILES: N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl, CC(C)C[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)C1=CN=CC=N1)B(O)O
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 75 years old or age < 75 years with abnormal cardiac, pulmonary, renal or
             hepatic function (unsuitable for protocol with standard inclusion/exclusion criteria).

          -  Patient is, in the investigator(s) opinion willing and able to comply with the
             protocol requirements.

          -  Patient has given voluntary written informed consent before performance of any
             study-related procedure not part of normal medical care, with the understanding that
             consent may be withdrawn by the patient at any time without prejudice to their future
             medical care.

          -  Male patient agrees to use an acceptable method for contraception (i.e., condom or
             abstinence) during study drug therapy (including dose interruption) and for 4 weeks
             after discontinuation of Velcade therapy.

          -  Female patient is either post-menopausal for 24 consecutive months or surgically
             sterilised or agree to continuous abstinence from heterosexual sexual contact or
             willing to use two acceptable method of birth control at the same time (one highly
             effective method and one additional effective method) (Highly Effective Methods:
             Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal
             ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm;
             Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug
             therapy (including dose interruption) and for 4 weeks after discontinuation of
             therapy.

          -  Patient was a newly diagnosed multiple myeloma based on standard criteria

          -  Patient has measurable disease, defined as follows:

          -  Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not
             necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA
             M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours;

          -  Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one
             plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs
             (i.e., MRI or CT scan).

          -  Patient has a Karnofsky performance status > 50%.

          -  Patient has a life-expectancy >3 months

          -  Pretreatment clinical laboratory values within 14 days of enrolment:

          -  platelet count ≥ 80x109/L

          -  hemoglobin ≥ 8 g/dL

          -  absolute neutrophil count (ANC) ≥ 1.0x109/L

          -  AST ≤ 2.5 times the upper limit of normal

          -  ALT ≤ 2.5 times the upper limit of normal

          -  total bilirubin ≤ 1.5 times the upper limit of normal

          -  cleareance creatinine ≥ 20 ml/min

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality or psychiatric illness that
             prevented the subject from signing the informed consent form or placed the subjects at
             unacceptable risk.

          -  Previous treatment with anti-myeloma therapy (does not include radiotherapy,
             bisphosphonates, or a single short course of steroid; < to the equivalent of
             dexamethasone 40 mg/day for 4 days).

          -  Pregnant or lactating females

          -  Known positive for HIV or active infectious hepatitis type A, B or C

          -  Peripheral neuropathy or neuropatic pain grade 2 or higher, as defined by National
             Cancer Institute Common Toxicity Criteria (NCI CTC) 3.0

          -  Infiltrative pulmonary disease