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Trial record 39 of 2516 for:    "Plasma Cell Neoplasm"

Interleukin-12 in Treating Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003149
Recruitment Status : Completed
First Posted : March 30, 2004
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: recombinant interleukin-12 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma
Study Start Date : December 1997
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003149

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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Overlook Hospital
Summit, New Jersey, United States, 07902-0220
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Martha Q. Lacy, MD Mayo Clinic

Publications of Results:
Lacy MQ, Blood E, Kay N, et al.: Interleukin-12 treatment for plateau phase multiple myeloma: an Eastern Cooperative Oncology Group (ECOG) phase II trial (E1A96). [Abstract] Blood 100 (11 pt 1): A-1549, 2002.

Layout table for additonal information Identifier: NCT00003149     History of Changes
Other Study ID Numbers: CDR0000065934
First Posted: March 30, 2004    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: March 2009

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents