Phase II Study of Autologous Myeloma-Derived Immunoglobulin Idiotype Conjugated to Keyhole Limpet Hemocyanin Plus Sargramostim (GM-CSF) in Patients With Multiple Myeloma Undergoing Second Autologous Peripheral Blood Stem Cell Transplantation
OBJECTIVES: I. Determine whether autologous myeloma-derived immunoglobulin idiotype
conjugated to keyhole limpet hemocyanin plus sargramostim (GM-CSF) can induce cellular and
humoral immunity against the unique idiotype expressed on the surface of myeloma cells in
patients with multiple myeloma undergoing second autologous peripheral blood stem cell
II. Determine the clinical efficacy and safety of this regimen in these patients.
PROTOCOL OUTLINE: Within 6 months after the first autologous peripheral blood stem cell
transplantation (APBSCT), patients receive melphalan IV over 30 minutes on day -2 and the
second APBSCT on day 0. Sargramostim (GM-CSF) is administered subcutaneously (SC) beginning
on day 1 and continuing until blood counts recover. Patients are also assigned to 1 of 3
Group 1: Patients receive autologous myeloma-derived immunoglobulin idiotype conjugated to
keyhole limpet hemocyanin (Id-KLH) SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, and
5 after the second APBSCT for a total of 3 vaccinations.
Group 2: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, 4, 5,
6, and 8 after the second APBSCT for a total of 6 vaccinations.
Group 3: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of weeks -8, -6, and
-2 before and months 2, 3, and 5 after the second APBSCT for a total of 6 vaccinations.
Patients are followed within 3 months and then every 6 months.
A maximum of 60 patients (20 per treatment group) will be accrued for this study within 3
Primary Purpose: Treatment
Larry W. Kwak
National Cancer Institute (NCI)
United States: Federal Government
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Medicine Branch||Bethesda, Maryland 20892|
|Arkansas Cancer Research Center||Little Rock, Arkansas 72205|