Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00470093|
Recruitment Status : Terminated (Low accrual)
First Posted : May 7, 2007
Results First Posted : November 16, 2018
Last Update Posted : November 16, 2018
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-α Biological: recombinant interleukin-6||Early Phase 1|
- 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 :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a|
|Actual Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: Interleukin-6 and Interferon-α
Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.
Biological: recombinant interferon-α
Biological: recombinant interleukin-6
- Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria. [ Time Frame: Up to 5 months ]Number of participants with partial or complete response by Bladé criteria where partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.
- Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events [ Time Frame: Up to 5 months ]Number of participants who discontinued the protocol due to adverse events.
- Optimal Dose of Interleukin-6 [ Time Frame: Up to 5 months ]Maximum tolerated dose found using a standard 3+3 dose escalation model.
- Impact of Treatment on Growth of Myeloma Cells [ Time Frame: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study ]Percentage change in growth of in vitro myeloma cells from baseline to end of study.
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 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 at Johns Hopkins|