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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Given IV
Given SC
Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Overall Survival
Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.
Time frame: 12.9 Median Years
Initial Response to Therapy
Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)
Time frame: Evaluated at Day +84-90 Post-Transplant
Time to Disease Progression
Time frame: 12.9 years (median)
Proportion of Patients Alive and in Remission
Time frame: 12.9 Median Years
Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
Time frame: First 100 days post-transplant
Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
Time frame: First 100 days post-transplant
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