Trial Outcomes & Findings for Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma (NCT NCT00470093)

Last Updated: 2018-11-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

3 participants

Primary outcome timeframe

Up to 5 months

Results posted on

2018-11-16

Participant Flow

One participant was a screen failure.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interleukin-6 and Interferon-α n=2 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 months

Outcome measures

Outcome measures
Measure	Interleukin-6 and Interferon-α n=2 Participants 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
Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.	0 Participants

PRIMARY outcome

Timeframe: Up to 5 months

Number of participants who discontinued the protocol due to adverse events.

Outcome measures

Outcome measures
Measure	Interleukin-6 and Interferon-α n=2 Participants 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
Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events	2 Participants

PRIMARY outcome

Timeframe: Up to 5 months

Population: 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.

Maximum tolerated dose found using a standard 3+3 dose escalation model.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study

Population: 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.

Percentage change in growth of in vitro myeloma cells from baseline to end of study.

Outcome measures

Outcome data not reported

Adverse Events

Interleukin-6 and Interferon-α

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interleukin-6 and Interferon-α n=2 participants at risk 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
General disorders Cold-like symptoms	100.0% 2/2 • Number of events 2 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Anorexia	100.0% 2/2 • Number of events 4 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Fever	100.0% 2/2 • Number of events 3 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Chills	100.0% 2/2 • Number of events 4 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Diaphoresis	100.0% 2/2 • Number of events 2 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Fatigue	100.0% 2/2 • Number of events 2 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Excessive sleepiness	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Flu-like symptoms	100.0% 2/2 • Number of events 2 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Weight loss	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Skin and subcutaneous tissue disorders Xerostomia	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Dehydration	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 3 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Investigations Anemia	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Musculoskeletal and connective tissue disorders Weakness	100.0% 2/2 • Number of events 4 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Nervous system disorders Confusion	100.0% 2/2 • Number of events 3 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Nervous system disorders Dizziness	100.0% 2/2 • Number of events 4 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Nervous system disorders Memory loss	100.0% 2/2 • Number of events 3 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Headache	100.0% 2/2 • Number of events 4 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 2/2 • Number of events 5 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Musculoskeletal and connective tissue disorders Myalgia	100.0% 2/2 • Number of events 3 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Musculoskeletal and connective tissue disorders Pain - neck	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 2/2 • Number of events 2 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 2/2 • Number of events 3 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Respiratory, thoracic and mediastinal disorders Voice changes	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Immune system disorders Salt sensitivity	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Insomnia	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Nervous system disorders Neuropathy	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
General disorders Constipation	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Nervous system disorders Depression	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Infections and infestations Upper respiratory tract infection	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.
Reproductive system and breast disorders Erectile dysfunction	50.0% 1/2 • Number of events 1 • Up to 5 months Adverse events were assessed every two weeks through the first two months of combination therapy, then monthly through the end of the study.

Additional Information

Dr. Carol Ann Huff

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-955-8842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place