Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's tissues. Peripheral stem cell transplantation with the person's own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: sargramostim Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Procedure: peripheral blood stem cell transplantation||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||April 2001|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- 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 regimen.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014508
|United States, Florida|
|Baptist Cancer Institute - Jacksonville|
|Jacksonville, Florida, United States, 32207-8554|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Massachusetts|
|Cancer Center at Tufts - New England Medical Center|
|Boston, Massachusetts, United States, 02111|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|MBCCOP-Our Lady of Mercy Cancer Center|
|Bronx, New York, United States, 10466|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University|
|Cleveland, Ohio, United States, 44106-5065|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Abramson Cancer Center at the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Neal Flomenberg, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|