Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
NCT ID: NCT00470093
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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TERMINATED
EARLY_PHASE1
3 participants
INTERVENTIONAL
2007-10-31
2010-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
recombinant interferon-α
recombinant interleukin-6
Interventions
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recombinant interferon-α
recombinant interleukin-6
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of recurrent multiple myeloma
* Must have received ≥ 2 prior therapies
PATIENT CHARACTERISTICS:
* Performance status 0-3
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Carol A Huff, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Other Identifiers
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