Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma
- Determine whether autologous peripheral blood stem cell transplantation (PBSCT)
followed by non-myeloablative allogeneic PBSCT is associated with no more than 20%
treatment-related mortality rates at 6 months in patients with multiple myeloma.
- Determine the response rate of patients treated with this regimen.
- Determine the percent donor chimerism in patients treated with this regimen.
- Determine the rate of graft-vs-host disease in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine whether abnormal cytogenetics at presentation correlate with poor response in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF)
subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell
(PBSC) collection is complete.
Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30
minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0.
Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.
Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30
minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients
undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and
continuing until blood counts recover.
Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice
daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3,
After day 120, patients with stable or progressive disease and no evidence of active GVHD
may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs
every 8 weeks.
Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then
annually for 15 years.
PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Kenneth C. Anderson, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Mount Sinai Medical Center||New York, New York 10029|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital||Pittsburgh, Pennsylvania 15224-1791|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Union Hospital Cancer Program at Union Hospital||Elkton MD, Maryland 21921|
|Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis||St Louis, Missouri 63110|