Clinical trial · Interventional
Interleukin-12 in Treating Patients With Multiple Myeloma
Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma
NCT00003149CI-TRIAL-00010948completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLacy MQ, Jacobus S, Blood EA, Kay NE, Rajkumar SV, Greipp PR. Phase II study of interleukin-12 for treatment of plateau phase multiple myeloma (E1A96): a trial of the Eastern Cooperative Oncology Group. Leuk Res. 2009 Nov;33(11):1485-9. doi: 10.1016/j.leukres.2009.01.020. Epub 2009 Feb 24. PMID 19243818