Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
Primary Purpose
Multiple Myeloma and Plasma Cell Neoplasm
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon-α
recombinant interleukin-6
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
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
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interleukin-6 and Interferon-α
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Optimal Dose of Interleukin-6
Maximum tolerated dose found using a standard 3+3 dose escalation model.
Impact of Treatment on Growth of Myeloma Cells
Percentage change in growth of in vitro myeloma cells from baseline to end of study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00470093
First Posted
May 3, 2007
Last Updated
October 18, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00470093
Brief Title
Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
Official Title
A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
October 2007 (Actual)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interleukin-6 and Interferon-α
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
recombinant interferon-α
Intervention Type
Biological
Intervention Name(s)
recombinant interleukin-6
Primary Outcome Measure Information:
Title
Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
Description
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.
Time Frame
Up to 5 months
Title
Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
Description
Number of participants who discontinued the protocol due to adverse events.
Time Frame
Up to 5 months
Title
Optimal Dose of Interleukin-6
Description
Maximum tolerated dose found using a standard 3+3 dose escalation model.
Time Frame
Up to 5 months
Title
Impact of Treatment on Growth of Myeloma Cells
Description
Percentage change in growth of in vitro myeloma cells from baseline to end of study.
Time Frame
Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Huff, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
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