Multiple Myeloma Clinical Trial
Official title:
Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that
were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes
the transplanted cells from a donor can make an immune response against the body's normal
cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed
by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together
with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating
patients who are undergoing a donor stem cell transplant for hematologic cancer, metastatic
breast cancer, or kidney cancer.
OBJECTIVES:
- Determine if a nonmyeloablative regimen comprising cyclophosphamide, fludarabine, and
radiotherapy followed by cyclosporine and mycophenolate mofetil provides a prompt and
durable donor engraftment in patients with hematologic malignancies or kidney cancer who
are undergoing allogeneic stem cell transplantation.
- Determine the safety of this nonmyeloablative transplantation regimen in these patients.
- Determine the risk of graft-versus-host-disease in patients treated with this regimen.
- Determine the antineoplastic potency of nonmyeloablative stem cell transplantation in
patients treated with this regimen.
- Determine the effect of lower doses of daily fludarabine on treatment-related mortality
(TRM) OUTLINE: Patients are stratified according to risk (standard vs high).
- Preparative regimen*: Patients receive cyclophosphamide intravenously (IV) over 2 hours
on day -6 and fludarabine IV over 1 hour on days -6 to -2. Patients undergo total body
irradiation on day -1. Some patients also receive anti-thymocyte globulin (ATG)** IV
every 12 hours on days -6 to -4. Patients who receive ATG* include the following:
- Related donor recipients who have not received combination chemotherapy within the
past 6 months
- Unrelated donor recipients who have not received combination chemotherapy within
the past 3 months
- Unrelated donor recipients who have received only 1 induction course for the
treatment of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML),
myelodysplastic syndromes (MDS), or blastic phase chronic myelogenous leukemia
(CML) NOTE: **Patients who underwent prior autologous stem cell transplantation in
the past year do not receive ATG.
- Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo
allogeneic PBSCT on day 0.
- Graft-versus-host-disease prophylaxis: Patients receive cyclosporine IV over 2 hours
beginning on day -3 and continuing until at least day 100. Patients also receive
mycophenolate mofetil IV or orally twice daily on days -3 to 30.
- Donor lymphocyte infusion (DLI): Patients without active GVHD but deteriorating donor
chimerism may receive DLI IV over 2 hours.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
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