Trial Outcomes & Findings for Treatment of POEMS Syndrome With Daratumumab (NCT NCT04396496)
NCT ID: NCT04396496
Last Updated: 2023-11-13
Results Overview
There is a one-point improvement in ECOG performance score; and/or ≥ 50% reduction in ONLS score at Day 360.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
360 days
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Daratumumab Injection
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Daratumumab Injection: DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
DARA injection will be given with oral lenalidomide for up to 12 four week cycles.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of POEMS Syndrome With Daratumumab
Baseline characteristics by cohort
| Measure |
Daratumumab Injection
n=2 Participants
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Daratumumab Injection: DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
DARA injection will be given with oral lenalidomide for up to 12 four week cycles.
|
|---|---|
|
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
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 360 daysThere is a one-point improvement in ECOG performance score; and/or ≥ 50% reduction in ONLS score at Day 360.
Outcome measures
| Measure |
Daratumumab Injection
n=2 Participants
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Daratumumab Injection: DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
DARA injection will be given with oral lenalidomide for up to 12 four week cycles.
|
|---|---|
|
Treatment Success
|
0 Participants
|
Adverse Events
Daratumumab Injection
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daratumumab Injection
n=2 participants at risk
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Daratumumab Injection: DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
DARA injection will be given with oral lenalidomide for up to 12 four week cycles.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
50.0%
1/2 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Daratumumab Injection
n=2 participants at risk
Up to 12 four-week cycles of Daratumumab (DARA), in combination with the immunomodulatory drug (IMiD) lenalidomide.
DARA is injected. Dosage calculated by weight.On Cycles 1 and 2, DARA is given on Days 1, 8,15 and 22. On Cycles 3-6,DARA is given on Days 1 and 15. On Cycles 7-12, DARA is given on Day 1.
Lenalidomide is taken by mouth. 15 mg on Days 1-21 of each cycle.
Daratumumab Injection: DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
DARA injection will be given with oral lenalidomide for up to 12 four week cycles.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
100.0%
2/2 • Number of events 2 • 3 years
|
|
General disorders
Fever
|
100.0%
2/2 • Number of events 2 • 3 years
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
2/2 • Number of events 2 • 3 years
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
2/2 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, Other, specify
|
50.0%
1/2 • Number of events 3 • 3 years
|
|
Vascular disorders
Flushing
|
50.0%
1/2 • Number of events 1 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
50.0%
1/2 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place