Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Biological: recombinant interferon-α
* Biological: recombinant interleukin-6


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of recurrent multiple myeloma Must have received ≥ 2 prior therapies PATIENT CHARACTERISTICS: Performance status 0-3 PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interleukin-6 and Interferon-α<br>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<br> <br> Biological: recombinant interleukin-6<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria. | 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. | Up to 5 months | 
| Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events | Number of participants who discontinued the protocol due to adverse events. | Up to 5 months | 
| Optimal Dose of Interleukin-6 | Maximum tolerated dose found using a standard 3+3 dose escalation model. | Up to 5 months | 
| Impact of Treatment on Growth of Myeloma Cells | Percentage change in growth of in vitro myeloma cells from baseline to end of study. | Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma