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

Early Phase 1

Terminated

Interventions: Biological: recombinant interferon-α
Biological: recombinant interleukin-6

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Interleukin-6 and Interferon-α	recombinant 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.
Interleukin-6 and Interferon-α	recombinant interleukin-6	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.

Primary Outcome Measures

Name	Time	Method
Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.	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	Up to 5 months	Number of participants who discontinued the protocol due to adverse events.
Optimal Dose of Interleukin-6	Up to 5 months	Maximum tolerated dose found using a standard 3+3 dose escalation model.
Impact of Treatment on Growth of Myeloma Cells	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.