Interleukin-12 in Treating Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00003149
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's blood cells to kill multiple myeloma cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-12 given at different times in treating patients with multiple myeloma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Hunterdon Regional Cancer Center
🇺🇸Flemington, New Jersey, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Cancer Center🇺🇸Indianapolis, Indiana, United States