Trial Outcomes & Findings for Daratumumab in Treatment of PGNMID and C3 GN (NCT NCT03095118)
NCT ID: NCT03095118
Last Updated: 2022-08-31
Results Overview
Number of treatment-emergent adverse events as defined as major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia, or thrombocytopenia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2022-08-31
Participant Flow
Participant milestones
| Measure |
Daratumumab
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Daratumumab
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Diagnosis not associated with monoclonal gammopathy
|
1
|
Baseline Characteristics
Daratumumab in Treatment of PGNMID and C3 GN
Baseline characteristics by cohort
| Measure |
Daratumumab
n=12 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 20.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
11 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
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of treatment-emergent adverse events as defined as major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia, or thrombocytopenia.
Outcome measures
| Measure |
Daratumumab
n=12 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Number of Treatment-Emergent Adverse Events
|
5 Serious Adverse Events
|
SECONDARY outcome
Timeframe: 6 monthsThe number of subjects to reach either complete remission or partial remission at 6 months after infusion.
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Remission Status at 6 Months
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe number of subjects to reach either complete remission or partial remission at 12 months after infusion.
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Remission Status at 12 Months
|
9 Participants
|
SECONDARY outcome
Timeframe: BaselineMeasured using 24 hour urine collection reported in mg/24h
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Proteinuria at Baseline
|
4346 mg/24h
Interval 3245.0 to 7943.0
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SECONDARY outcome
Timeframe: 6 monthsMeasured using 24 hour urine collection reported in mg/24 h
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Proteinuria at 6 Months
|
702 mg/24h
Interval 435.0 to 3057.0
|
SECONDARY outcome
Timeframe: 12 monthsMeasured using 24 hour urine collection reported in mg/24h
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Proteinuria at 12 Months
|
1264 mg/24h
Interval 463.0 to 3645.0
|
SECONDARY outcome
Timeframe: BaselineBlood serum collected and reported in mg/dL
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Serum Creatinine at Baseline
|
1.36 mg/dL
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: 6 monthsBlood serum collected and reported in mg/dL
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Serum Creatinine at 6 Months
|
1.25 mg/dL
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 12 monthsBlood serum collected and reported in mg/dL
Outcome measures
| Measure |
Daratumumab
n=10 Participants
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Serum Creatinine at 12 Months
|
1.25 mg/dL
Standard Deviation 0.52
|
Adverse Events
Daratumumab
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daratumumab
n=12 participants at risk
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Eye disorders
Eye Chemosis
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Eye disorders
Acute Glaucoma
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Infections and infestations
C. difficile infection
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
Other adverse events
| Measure |
Daratumumab
n=12 participants at risk
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Daratumumab: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
|
|---|---|
|
Renal and urinary disorders
UTI
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Infections and infestations
URI
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
58.3%
7/12 • Number of events 16 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
58.3%
7/12 • Number of events 10 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Throat Irritation
|
50.0%
6/12 • Number of events 11 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Eye disorders
Blurred Vision
|
33.3%
4/12 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Tingling in feet
|
25.0%
3/12 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Flushed
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Eye disorders
Watery eyes
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Itching
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Sneezing
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Chest tightness
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Cardiac disorders
Vagal response
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Lip tingling
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Skin and subcutaneous tissue disorders
Skin itchy at IV site
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Hoarse voice
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Sensation of facial swelling
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Nausea
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Insomnia
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Night sweats
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Sore throat
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Skin and subcutaneous tissue disorders
Sore scalp
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Chills
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Nervous system disorders
Restless legs
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Sore in mouth
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Gastrointestinal disorders
Rectal bleeding
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
General disorders
Foot pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
|
Gastrointestinal disorders
Bloating
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 1 year on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place