Refractory Multiple Myeloma Clinical Trial
Official title:
Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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