combination high dose melphalan and autologous peripheral blood stem cell (pbsc) transplant with bortezomib for multiple myeloma: a dose and schedule finding study

Conditions: Cancer; Multiple Myeloma

Summary: the goal of this study is to evaluate the safety of melphalan and autologous pbsct (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new fda approved drug used to treat myeloma.


Eligibility criteria:
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 * patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care * patient is, in the investigator's opinion, willing and able to comply with the protocol requirements *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 exclusion criteria: * unsupportable anemia with \< 10b/dl * patient has a calculated or measured creatinine clearance of \< 30ml/min within 14 days before enrollment * patient has ≥ grade 2 peripheral neuropathy within 14 days before enrollment * patient has hypersensitivity to bortezomib, boron or mannitol * patient has had an allergic reaction to melphalan or chlorambucil * female subject is pregnant or breast-feeding. confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test result obtained during screening. pregnancy testing is not required for post-menopausal or surgically sterilized women. * patient has received other investigational drugs with 14 days before enrollment * serious medical or psychiatric illness likely to interfere with participation in this clinical study * cardiac or pulmonary dysfunction such that patients do not meet institutional pre-transplant evaluation criteria * known central nervous system involvement or suspicion of involvement with myeloma * other active malignancies (with the exception of basal and squamous cell skin cancer) within 5 years of study entry. patients with treated prostate or cervical cancer in situ who are 2 or more years from therapy and remain free of disease may be entered into the study at the investigator's discretion. * known to be hiv positive, hiv-1 positive

Keywords: cancer multiple myeloma peripheral blood stem cell transplant