Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

Inclusion Criteria

• •Patients with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant
• •Male and female subjects between the age of 18 and 70 years.
• •Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care
• •Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
• •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• •Male subjects agrees to use an acceptable method for contraception for the duration of the study.
• •Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy prior to study initiation
• •Patient has achieved less than 90% disease reduction from previous treatment prior to transplant (as measured by serum or urine protein electrophoresis) and has more than 5% plasma cells in the bone marrow, or patient has progressed and has more than 5% plasma cells in the bone marrow.
• •Karnofsky Performance Status score of ≥ 60%
• •Patient has met the following laboratory requirements prior to Day -4
• •Platelet count ≥ 50, 000/mm3
• •Absolute Neutrophil Count ≥ 500/mm3
• •Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion)
• •Calculated creatinine clearance ≥ 30mL/min
• •Toxic effects of previous therapy or surgery resolved to Grade 2 or better