Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
- Patients with multiple myeloma who are eligible for an autologous peripheral blood
- 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knowledge that consent can be withdrawn at anytime without prejudice to future
- Patient is, in the investigator's opinion, willing and able to comply with the
- 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
- 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
- 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