A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma
- Determine the incidence of early mortality in patients with multiple myeloma treated
with melphalan and autologous peripheral blood stem cell (PBSC) transplantation
followed by fludarabine, cyclophosphamide, and allogeneic PBSC transplantation.
- Determine the incidence of early allogeneic graft failure (before day 100 after
allogeneic PBSC transplantation) and the incidence of severe acute graft-versus-host
disease (GVHD) in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Correlate changes in the T-cell population with clinical outcome, such as survival, in
patients treated with this regimen.
- Correlate changes in the T-cell population with the incidence of GVHD, use of
immunosuppressive agents, and effects of fludarabine in patients treated with this
- Determine the degree of chimerism after allogeneic PBSC transplantation and the time
course over which it is established in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive melphalan IV over 15 minutes on day -1. Autologous peripheral blood stem
cells (PBSCs) are reinfused on day 0. Patients also receive sargramostim (GM-CSF)
subcutaneously (SC) or IV over at least 30 minutes daily beginning on day 1 and continuing
until blood counts recover. Beginning 100-182 days after autologous PBSC transplantation,
patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV
over 1-2 hours on days -3 and -2. Allogeneic PBSCs are infused on day 0. Patients may
receive a second allogeneic PBSC infusion on day 1. Patients also receive GM-CSF SC or IV
over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover.
Cyclosporine is administered IV or orally twice daily as graft-versus-host disease (GVHD)
prophylaxis, beginning on day -1 and continuing until day 60, followed by a taper in the
absence of GVHD.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total 19-46 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Neal Flomenberg, MD
Kimmel Cancer Center (KCC)
United States: Federal Government
|Mayo Clinic - Jacksonville
|Jacksonville, Florida 32224
|Mayo Clinic Cancer Center
|Rochester, Minnesota 55905
|Beth Israel Deaconess Medical Center
|Boston, Massachusetts 02215
|CCOP - Northern New Jersey
|Hackensack, New Jersey 07601
|Penn State Cancer Institute at Milton S. Hershey Medical Center
|Hershey, Pennsylvania 17033-0850
|Cancer Center at Tufts - New England Medical Center
|Boston, Massachusetts 02111
|MetroHealth's Cancer Care Center at MetroHealth Medical Center
|Cleveland, Ohio 44106
|Abramson Cancer Center at the University of Pennsylvania
|Philadelphia, Pennsylvania 19104
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
|Cleveland, Ohio 44106
|Baptist Cancer Institute - Jacksonville
|Jacksonville, Florida 32207
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
|New Brunswick, New Jersey 08903
|MBCCOP-Our Lady of Mercy Cancer Center
|Bronx, New York 10466