Expired Study
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Atlanta, Georgia 30322


Purpose:

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.


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 - Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care - Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements -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


NCT ID:

NCT00793650


Primary Contact:

Principal Investigator
Sagar Lonial, MD
Emory University Winship Cancer Institute


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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