Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
Condition: Refractory Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of
      chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using
      stem cells from the patient or an identical brother or sister, may allow more chemotherapy to
      be given so more cancer cells are killed. Giving maintenance therapy after a stem cell
      transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan
      is more effective in treating multiple myeloma (MM).

      PURPOSE: This randomized phase III trial is studying two different doses of melphalan to
      compare how well they work when given together with amifostine followed by one or two
      autologous or syngeneic stem cell transplants and maintenance therapy in treating patients
      with stage II-III MM
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Compare the complete response (CR) and near CR rate in patients undergoing autologous stem
      cell transplant (ASCT) using melphalan 280 mg/m^2 or melphalan 200 mg/m^2.

      SECONDARY OBJECTIVES:

      I. Compare toxicities between patients receiving amifostine and melphalan 280 mg/m^2 or
      melphalan 200 mg/m^2.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      INDUCTION THERAPY:

      ARM I (HIGH DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine intravenously (IV)
      over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on
      day 2.

      ARM II (LOW DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine as in arm I and
      melphalan as in arm I at a lower dose.

      AUTOLOGOUS OR SYNGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION (PBSCT): At least 20 hours
      after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.

      Patients undergo restaging of the disease between days 80-90. Patients with progressive
      disease are removed from the study. Patients who achieve a CR or near-CR can proceed to
      optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo
      additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.

      Patients again undergo restaging of the disease 80-90 days later. Patients with progressive
      disease are removed from the study. Patients without progressive disease can proceed to
      maintenance therapy.

      After completion of study treatment, patients are followed up every 3 months for 5 years.
    

Intervention name(s): melphalan; amifostine trihydrate; peripheral blood stem cell transplantation; fluorescence in situ hybridization; bone marrow ablation with stem cell support
Intervention type(s): Drug; Drug; Procedure; Genetic; Procedure
Intervention description(s): Given IV; Given IV; Undergo PBSCT; Correlative study; Undergo transplant
Other intervention name(s): Alkeran; CB-3025; L-PAM; L-phenylalanine mustard; L-Sarcolysin; ethiofos; Ethyol; gammaphos; WR-2721; PBPC transplantation; PBSC transplantation; peripheral blood progenitor cell transplantation; transplantation, peripheral blood stem cell; fluorescence in situ hybridization (FISH)
Intervention MeSH terms: Melphalan; Amifostine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment