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Trial record 53 of 2571 for:    "Plasma Cell Neoplasm"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00470093
Recruitment Status : Terminated (Low accrual)
First Posted : May 7, 2007
Results First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Biological: recombinant interferon-α
Biological: recombinant interleukin-6
Enrollment 3
Recruitment Details  
Pre-assignment Details One participant was a screen failure.
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
54.5
(50 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
Hide Description Number of participants who discontinued the protocol due to adverse events.
Time Frame Up to 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
3.Primary Outcome
Title Optimal Dose of Interleukin-6
Hide Description Maximum tolerated dose found using a standard 3+3 dose escalation model.
Time Frame Up to 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome cannot be evaluated as zero participants tolerated the study regimen. All participants were enrolled on the 2.5 mg arm and a maximum tolerated dose was not found.
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Impact of Treatment on Growth of Myeloma Cells
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants tolerated protocol therapy and the research sample blood draws were therefore not completed as planned. Because of this, the data from this outcome could not be collected.
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 5 months
Adverse Event Reporting Description Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
 
Arm/Group Title Interleukin-6 and Interferon-α
Hide Arm/Group 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.

recombinant interferon-α

recombinant interleukin-6

All-Cause Mortality
Interleukin-6 and Interferon-α
Affected / at Risk (%)
Total   0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Interleukin-6 and Interferon-α
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interleukin-6 and Interferon-α
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Gastrointestinal disorders   
Nausea  1  2/2 (100.00%)  3
General disorders   
Cold-like symptoms  1  2/2 (100.00%)  2
Anorexia  1  2/2 (100.00%)  4
Fever  1  2/2 (100.00%)  3
Chills  1  2/2 (100.00%)  4
Diaphoresis  1  2/2 (100.00%)  2
Fatigue  1  2/2 (100.00%)  2
Excessive sleepiness  1  1/2 (50.00%)  1
Flu-like symptoms  1  2/2 (100.00%)  2
Weight loss  1  1/2 (50.00%)  1
Dehydration  1  1/2 (50.00%)  1
Headache  1  2/2 (100.00%)  4
Insomnia  1  1/2 (50.00%)  1
Constipation  1  1/2 (50.00%)  1
Immune system disorders   
Salt sensitivity  1  1/2 (50.00%)  1
Infections and infestations   
Upper respiratory tract infection  1  1/2 (50.00%)  1
Investigations   
Anemia  1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Weakness  1  2/2 (100.00%)  4
Arthralgia  1  2/2 (100.00%)  5
Myalgia  1  2/2 (100.00%)  3
Pain - neck  1  1/2 (50.00%)  1
Nervous system disorders   
Confusion  1  2/2 (100.00%)  3
Dizziness  1  2/2 (100.00%)  4
Memory loss  1  2/2 (100.00%)  3
Neuropathy  1  1/2 (50.00%)  1
Depression  1  1/2 (50.00%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/2 (100.00%)  2
Cough  1  2/2 (100.00%)  3
Voice changes  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Xerostomia  1  1/2 (50.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carol Ann Huff
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8842
EMail: huffca@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00470093     History of Changes
Other Study ID Numbers: J0620
P30CA006973 ( U.S. NIH Grant/Contract )
P01CA015396 ( U.S. NIH Grant/Contract )
NA_00002178 ( Other Identifier: JHMIRB )
First Submitted: May 3, 2007
First Posted: May 7, 2007
Results First Submitted: October 18, 2018
Results First Posted: November 16, 2018
Last Update Posted: November 16, 2018