Trial Outcomes & Findings for Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401 (NCT NCT02363439)
NCT ID: NCT02363439
Last Updated: 2018-01-09
Results Overview
Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
During receipt of study treatment on the trial.
Results posted on
2018-01-09
Participant Flow
Participant milestones
| Measure |
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
|
|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
Baseline Characteristics
Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
Baseline characteristics by cohort
| Measure |
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
n=5 Participants
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 twice weekly per Protocol 8400-401
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 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
|
5 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
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During receipt of study treatment on the trial.Population: Safety population
Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
Outcome measures
| Measure |
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
n=5 Participants
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
|
|---|---|
|
Number of Participants With Adverse Events
|
4 Participants
|
Adverse Events
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
n=5 participants at risk
Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Eye disorders
Conjunctival hemorrhage
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
General disorders
Asthenia
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
General disorders
Influenza like illness
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
General disorders
Injection site bruising
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
General disorders
Injection site discoloration
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
General disorders
Injection site erythema
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
General disorders
Edema peripheral
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Injury, poisoning and procedural complications
Excoriation
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
20.0%
1/5 • During receipt of study treatment on the trial.
An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place