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Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven plateau phase multiple myeloma at original
diagnosis: Bone marrow plasmacytosis with greater than 10% plasma cells, sheets of plasma
cells, or biopsy proven plasmacytoma Must be in stable plateau phase requiring objective
response, no evidence of continuing improvement by any criteria, and less than 20%
variation in M protein at least 4 weeks prior to study Must have at least one of the
following at original diagnosis: M protein in serum or urine X-ray evidence of osteolytic
lesion Measurable or evaluable M protein Serum M protein greater than 1.0 g/dL Urine M
protein greater than 200 mg/24 hours M protein less than these values will be considered
evaluable (serum less than 1 g/dL or urine less than 200 mg/24 hours) Nonsecretory
patients are ineligible

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy:
Not specified Hematopoietic: WBC at least 2,500/mm3 Absolute neutrophil count at least
1,250/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper
limit of normal (ULN) SGOT less than 1.5 times ULN Renal: Creatinine clearance at least 50
mL/min Cardiovascular: No New York Heart Association class III or IV congestive heart
failure Other: Not pregnant or nursing Fertile patients must use effective contraception
No uncontrolled peptic ulcer disease No inflammatory bowel disease No history of
significant autoimmune disease (rheumatoid arthritis or systemic lupus erythematosus)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 60 days since prior biologic response
modifiers At least 60 days since prior bone marrow transplantation Chemotherapy: At least
60 days since prior chemotherapy Endocrine therapy: No concurrent corticosteroids
Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Martha Q. Lacy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

September 2006

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



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