Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00470093|
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : January 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: recombinant interferon alfa Biological: recombinant interleukin-6||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Official Title:||A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||January 2010|
U.S. FDA Resources
- Response rate
- Optimal dose
- Impact of treatment on clonogenic growth of myeloma cells in serial in vitro assays
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|