Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

        -  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.
    

Intervention name(s): sargramostim; cyclophosphamide; cyclosporine; fludarabine phosphate; melphalan; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Melphalan; Fludarabine; Fludarabine phosphate; Cyclosporins; Sargramostim
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma