Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00470093
- 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
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins🇺🇸Baltimore, Maryland, United States