Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma
OBJECTIVES: I. Evaluate the antitumor activity of interleukin-12 (IL-12) in patients with
plateau phase multiple myeloma. II. Evaluate the toxic effects of IL-12 in these patients.
III. Evaluate the effectiveness of IL-12 in augmenting T helper subsets in these patients.
OUTLINE: This is a randomized study. Patients are stratified by prior bone marrow
transplantation (yes vs no) and by prior pneumococcal vaccine (Pnu-Immune-23) (yes vs no or
unknown). Patients are randomized to one of two treatment arms: Arm I: Patients receive
Haemophilus influenzae b vaccine (Hib TITER) and Pnu-Immune-23 on day 1 during week 1.
Patients who have received Pnu-Immune-23 within the past 3 years receive Hib TITER but no
Pnu-Immune-23. Patients receive low dose interleukin-12 (IL-12) subcutaneously (SQ) twice a
week during weeks 1 and 2. Beginning on day 1 of week 3, patients receive high dose IL-12 SQ
twice a week for an additional 12 weeks. Arm II: Patients receive Hib TITER and
Pnu-Immune-23 as in arm I. Patients undergo observation during weeks 1-4, then receive low
dose IL-12 SQ twice a week during weeks 5 and 6. Beginning on day 1 of week 7, patients
receive high dose IL-12 SQ twice a week for an additional 12 weeks. Both arms: Patients
without disease progression may continue to receive high dose IL-12 for an additional 14
weeks. Patients are followed every 3 months for the first 2 years, every 6 months for the
next 3 years, and then annually thereafter until death.
PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Martha Q. Lacy, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Rochester Cancer Center||Rochester, New York 14642|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)||Indianapolis, Indiana 46202|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|Hahnemann University Hospital||Philadelphia, Pennsylvania 19102-1192|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|Morristown Memorial Hospital||Morristown, New Jersey 07962-1956|
|Hunterdon Regional Cancer Center||Flemington, New Jersey 08822|
|Overlook Hospital||Summit, New Jersey 07902-0220|