Status:
TERMINATED
Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
Lead Sponsor:
Emory University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Cancer
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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- Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00793650
Start Date
May 1 2005
End Date
September 1 2011
Last Update
August 30 2012
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322