Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate 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: Giving chemotherapy, such as melphalan and busulfan, before a donor peripheral
      blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the
      patient's immune system from rejecting the donor's stem cells. When the healthy stem cells
      from a donor are infused into the patient they may help the patient's bone marrow make stem
      cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells
      from a donor can make an immune response against the body's normal cells. Giving tacrolimus
      and methotrexate before or after transplant may stop this from happening.

      PURPOSE: This phase II trial is studying how well giving melphalan together with busulfan
      followed by donor peripheral stem cell transplant, tacrolimus, and methotrexate works in
      treating patients with multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate transplant-related mortality in patients with multiple myeloma treated with a
           myeloablative conditioning regimen comprising melphalan and busulfan followed by
           HLA-matched, allogeneic peripheral blood stem cell transplantation (PBSCT) and
           graft-vs-host disease prophylaxis with tacrolimus and methotrexate.

      Secondary

        -  Determine the disease response in patients treated with this regimen.

        -  Determine the 1-year progression-free survival and overall survival in patients treated
           with this regimen.

      OUTLINE:

        -  Conditioning regimen: Patients receive melphalan IV over 30 minutes on day -6 and
           busulfan IV over 3 hours on days -5 to -3.

        -  Peripheral blood stem cell transplantation (PBSCT): Patients undergo HLA-matched,
           related donor, allogeneic PBSCT on day 0.

        -  Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV
           continuously or orally twice daily beginning on day -2 and continuing until day 80
           followed by a taper until day 180 in the absence of GVHD or disease progression.
           Patients also receive methotrexate IV on days 1, 3, 6, and 11.

      After completion of study treatment, patients are followed every 6 months for 2 years and
      then annually thereafter.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): busulfan; melphalan; methotrexate; tacrolimus; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Methotrexate; Melphalan; Busulfan; Tacrolimus
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma