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Allogeneic Stem Cell Transplantation For Multiple Myeloma: A Two Step Approach To Reduce Toxicity Involving High Dose Melphalan and Autologous Stem Cell Transplant Followed By PBSC Allografting After Low Dose TBI (NCT00003954)

National Cancer Institute (NCI)
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
  • Drug: melphalan
    Given IV
    • Alkeran
    • CB-3025
    • L-PAM
    • L-phenylalanine mustard
    • L-Sarcolysin
  • Procedure: autologous hematopoietic stem cell transplantation
    Undergo autologous bone marrow or PBSCT
    • Procedure: autologous bone marrow transplantation
      Undergo autologous bone marrow or PBSCT
      • ABMT
      • bone marrow transplantation, autologous
      • transplantation, autologous bone marrow
    • Procedure: peripheral blood stem cell transplantation
      Undergo autologous bone marrow or PBSCT
      • PBPC transplantation
      • PBSC transplantation
      • peripheral blood progenitor cell transplantation
      • transplantation, peripheral blood stem cell
    • Radiation: total-body irradiation
      Undergo TBI
      • TBI
    • Procedure: peripheral blood stem cell transplantation
      Undergo donor PBSCT
      • PBPC transplantation
      • PBSC transplantation
      • peripheral blood progenitor cell transplantation
      • transplantation, peripheral blood stem cell
    • Drug: cyclosporine
      Given IV and PO
      • ciclosporin
      • cyclosporin
      • cyclosporin A
      • CYSP
      • Sandimmune
    • Drug: mycophenolate mofetil
      Given PO
      • Cellcept
      • MMF
    • Biological: therapeutic allogeneic lymphocytes
      Undergo DLI
      • ALLOLYMPH
    Ages eligible for Study
    up to 65 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis or have received chemotherapy and/or radiation therapy for progressive MM after initial diagnosis of stage I disease
    • The patient must have the capacity to give informed consent
    • Have received at least 4 cycles of conventional dose chemotherapy for MM
    • DONOR: HLA genotypically identical sibling
    • DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for both peripheral blood stem cell (PBSC) allograft and subsequent DLI
    • DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)
    • DONOR: Age < 75, older donors may be considered after consultation by Psychological Consultation Center (PCC)
    Exclusion Criteria:
    • Karnofsky score less than 60, unless due solely to myeloma
    • Left ventricular ejection fraction less than 40%
    • Bilirubin greater than 2 X the upper limit of normal
    • Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 X the upper limit of normal
    • Diffusion lung capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen
    • Patients with poorly controlled hypertension
    • Pregnancy
    • Seropositive for the human immunodeficiency virus
    • Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
    • Creatinine clearance < 40 cc/min at the time of initial autografting evaluation
    • Prior autograft (can be treated on alternative protocol)
    • DONOR: Identical twin
    • DONOR: Age less than 12 years
    • DONOR: Pregnancy
    • DONOR: Infection with human immunodeficiency virus (HIV)
    • DONOR: Inability to achieve adequate venous access
    • DONOR: Known allergy to G-CSF
    • DONOR: Current serious systemic illness
    • DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation as described in the standard practice guidelines of the institution
    PRIMARY OBJECTIVES:

    I. To evaluate engraftment of human leukocyte antigen (HLA) identical peripheral blood stem cell (PBSC) allografts given after conditioning with total-body irradiation (TBI) (200 cGy) and post-grafting immunosuppression with cyclosporine (CSP)/mycophenolate mofetil (MMF) in myeloma patients initially cytoreduced with high-dose melphalan.

    II. To evaluate non-relapse mortality at day 100 post allografting. III. To evaluate the efficacy of this allografting strategy in terms of long-term progression free survival (PFS).

    OUTLINE:

    CONDITIONING REGIMEN: Patients receive high-dose melphalan intravenously (IV) over 15-20 minutes on day -2.

    TRANSPLANTATION: Patients undergo autologous bone marrow or PBSC transplantation (PBSCT) on day 0.

    NON-MYELOABLATIVE CONDITIONING REGIMEN: Beginning 40-120 days after autologous transplant, patients undergo TBI on day 0.

    TRANSPLANTATION: Patients undergo donor PBSCT on day 0.

    IMMUNOSUPPRESSION: Patients receive cyclosporine IV twice daily (BID) on days -1 and 0 and orally (PO) BID on days 1-80 with taper based on evaluation of disease response and graft-versus-host disease (GVHD). Patients also receive mycophenolate mofetil PO BID on days 0-27.

    POST-TRANSPLANTATION DONOR LYMPHOCYTE INFUSION (DLI): Beginning 4 weeks after immunosuppression, patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments.

    After completion of study treatment, patients are followed up for 3 years.

    4 locations

    Status:
    active not recruiting
    Type:
    Interventional
    Phase:
    Ⅰ, Ⅱ
    Start:
    28 February, 1999
    Updated:
    21 May, 2017
    Participants:
    40
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