Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy

Multiple Myeloma Clinical Trial

Official title: Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes
• Neoplasms, Plasma Cell
• Plasma Cell Neoplasm
• Plasmacytoma

• NCT number: NCT00303719
• Study type: Interventional
• Source: Masonic Cancer Center, University of Minnesota
• Status: Terminated
• Phase: Phase 2
• Start date: March 26, 2002
• Completion date: May 8, 2019