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

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Melphalan

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• Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care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