Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
Condition: Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies the effectiveness of melphalan, peripheral stem cell
      transplantation, and interleukin-2 followed by interferon alfa in treating patients who have
      advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor
      cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem
      cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
      more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill
      multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate initial response to therapy, time to disease progression, and overall survival in
      MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and
      sequential IL2.

      SECONDARY OBJECTIVES:

      I. Evaluate grade 3-4 toxicities encountered by younger (< 56 years old) and older (>56 years
      old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral
      blood stem cells, and sequential IL2.

      OUTLINE:

      Patients receive melphalan intravenously (IV) over 2-3 hours on day -2 and an infusion of
      IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day
      0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment
      with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance
      therapy comprising interferon alfa subcutaneously (SC) 3 times a week in the absence of
      disease progression or unacceptable toxicity.
    

Intervention name(s): melphalan; recombinant interferon alfa; aldesleukin; in vitro-treated peripheral blood stem cell transplantation
Intervention type(s): Drug; Biological; Biological; Procedure
Intervention description(s): Given IV; Given SC; Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion; Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
Other intervention name(s): Alkeran; CB-3025; L-PAM; L-phenylalanine mustard; L-Sarcolysin; Alferon N; alpha interferon; IFN-A; Intron A; Roferon-A; IL-2; Proleukin; recombinant human interleukin-2; recombinant interleukin-2; in vitro-treated PBPC transplantation; in vitro-treated PBSC; in vitro-treated peripheral blood progenitor cell transplantation; PBPC transplantation, in vitro-treated; peripheral blood progenitor cell transplantation, in vitro-treated
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin; Interferon alpha-2; Melphalan; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment