Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Biological: recombinant interferon alfa
Biological: recombinant interleukin-6
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a|
- Response rate [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Optimal dose [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Impact of treatment on clonogenic growth of myeloma cells in serial in vitro assays [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
- Determine the safety and optimal dose of this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.
OUTLINE: This is a pilot study.
Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470093
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Carol A. Huff, MD||Sidney Kimmel Comprehensive Cancer Center|