Trial Outcomes & Findings for QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01670994)
NCT ID: NCT01670994
Last Updated: 2024-06-18
Results Overview
Number of treatment related AEs that occur or worsen after the first dose of study treatment
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
7 weeks
Results posted on
2024-06-18
Participant Flow
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
Participant milestones
| Measure |
ALT-801 0.04mg/kg
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
ALT-801 0.06mg/kg
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
ALT-801 0.04mg/kg
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
ALT-801 0.06mg/kg
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
|---|---|---|
|
Overall Study
Disease Progression and Switched to Alternative Treatment
|
0
|
1
|
|
Overall Study
Disease Progression and Did Not Qualify or Consent for Repeat Treatment
|
0
|
1
|
|
Overall Study
Patient experienced DLT
|
0
|
1
|
Baseline Characteristics
QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
ALT-801 0.04mg/kg
n=3 Participants
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
ALT-801 0.06mg/kg
n=3 Participants
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 6.9 • n=93 Participants
|
64 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
66 years
STANDARD_DEVIATION 5.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Patients with Relapsed or Refractory Multiple Myeloma
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 7 weeksNumber of treatment related AEs that occur or worsen after the first dose of study treatment
Outcome measures
| Measure |
ALT-801 0.04mg/kg
n=3 Participants
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
ALT-801 0.06mg/kg
n=3 Participants
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events
|
3 Participants
|
3 Participants
|
Adverse Events
ALT-801 0.04mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
ALT-801 0.06mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ALT-801 0.04mg/kg
n=3 participants at risk
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
ALT-801 0.06mg/kg
n=3 participants at risk
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
|---|---|---|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
Other adverse events
| Measure |
ALT-801 0.04mg/kg
n=3 participants at risk
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
ALT-801 0.06mg/kg
n=3 participants at risk
ALT-801: Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
|
|---|---|---|
|
General disorders
Influenza like illness
|
100.0%
3/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
General disorders
Oedema peripheral
|
100.0%
3/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
General disorders
Fatigue
|
33.3%
1/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Anal fissure
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
3/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
2/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Nervous system disorders
Akathisia
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Vascular disorders
Flushing
|
66.7%
2/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From start of treatment up to 72 days
|
66.7%
2/3 • From start of treatment up to 72 days
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From start of treatment up to 72 days
|
33.3%
1/3 • From start of treatment up to 72 days
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • From start of treatment up to 72 days
|
0.00%
0/3 • From start of treatment up to 72 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place