Clinical Trial: S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis.


Detailed Summary:

OBJECTIVES:

  • Determine overall survival of patients with high-risk multiple myeloma, primary systemic amyloidosis, or light chain deposition disease treated with two courses of modified high-dose melphalan and autologous peripheral blood stem cell transplantation.
  • Determine the hematologic response in patients treated with this regimen.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the prognostic significance of cytogenetic markers in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (high-risk multiple myeloma vs primary systemic amyloidosis vs both).

  • Induction therapy (multiple myeloma patients only): Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral thalidomide daily on days 1-35. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity.

  • Mobilization and stem cell collection:

    • Multiple myeloma patients: Within 28-35 days after completion of induction therapy, patients receive cyclophosphamide IV over 2-3 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 2 and continuing through the day before the last leukapheresis. Usage of mesna IV on day 1 (prior to and twice after cyclophosphamide administration is recommended).
    • Primary systemic amyloidosis patients: Patients receive G-CSF SC daily beginning o
      Sponsor: Southwest Oncology Group

      Current Primary Outcome: Overall survival [ Time Frame: 5 years ]

      Original Primary Outcome:

      Current Secondary Outcome:

      • Hematologic response [ Time Frame: 5 years ]
      • Qualitative and quantitative toxicity [ Time Frame: 5 years ]
      • Prognostic significance of cytogenetic markers [ Time Frame: 5 years ]


      Original Secondary Outcome:

      Information By: Southwest Oncology Group

      Dates:
      Date Received: July 8, 2003
      Date Started: January 2004
      Date Completion: November 2015
      Last Updated: April 1, 2015
      Last Verified: April 2015