Trial Outcomes & Findings for Ixazomib, Cyclophosphamide and Dexamethasone for Multiple Myeloma (NCT NCT02412228)
NCT ID: NCT02412228
Last Updated: 2025-10-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Through study treatment completion, an average of 2 years
Results posted on
2025-10-15
Participant Flow
Participant milestones
| Measure |
Ixazomib Regimen
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Ixazomib: Cycle 1:
Ixazomib: 4mg/day 1, 8, 15
Cycles 2-6:
Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Cyclophosphamide: Cycle 1:
Cyclophosphamide: 50 mg/day continuous daily
Cycles 2-6:
Cyclophosphamide: 50 mg/day continuous daily
Dexamethasone: Cycle 1:
Dexamethasone: 20 mg/day 1, 8, 15
Cycles 2-6:
Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ixazomib Regimen
n=12 Participants
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Ixazomib: Cycle 1:
Ixazomib: 4mg/day 1, 8, 15
Cycles 2-6:
Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Cyclophosphamide: Cycle 1:
Cyclophosphamide: 50 mg/day continuous daily
Cycles 2-6:
Cyclophosphamide: 50 mg/day continuous daily
Dexamethasone: Cycle 1:
Dexamethasone: 20 mg/day 1, 8, 15
Cycles 2-6:
Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=12 Participants
|
|
Age, Continuous
|
61 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
|
Region of Enrollment
United States
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12 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Through study treatment completion, an average of 2 yearsOutcome measures
| Measure |
Ixazomib Regimen
n=12 Participants
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Ixazomib: Cycle 1:
Ixazomib: 4mg/day 1, 8, 15
Cycles 2-6:
Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Cyclophosphamide: Cycle 1:
Cyclophosphamide: 50 mg/day continuous daily
Cycles 2-6:
Cyclophosphamide: 50 mg/day continuous daily
Dexamethasone: Cycle 1:
Dexamethasone: 20 mg/day 1, 8, 15
Cycles 2-6:
Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
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|---|---|
|
Evaluation of the Response Rate of Ixazomib With Metronomic Cyclophosphamide and Dexamethasone for First-line Treatment of Multiple Myeloma.
|
12 Participants
|
SECONDARY outcome
Timeframe: Assessed at baseline and end of study, up to 2 years, end of study reportedOutcome measures
| Measure |
Ixazomib Regimen
n=12 Participants
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Ixazomib: Cycle 1:
Ixazomib: 4mg/day 1, 8, 15
Cycles 2-6:
Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Cyclophosphamide: Cycle 1:
Cyclophosphamide: 50 mg/day continuous daily
Cycles 2-6:
Cyclophosphamide: 50 mg/day continuous daily
Dexamethasone: Cycle 1:
Dexamethasone: 20 mg/day 1, 8, 15
Cycles 2-6:
Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
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|---|---|
|
Evaluation of the Toxicities Associated With Ixazomib With Metronomic Cyclophosphamide and Dexamethasone.
|
12 Participants
|
Adverse Events
Ixazomib Regimen
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixazomib Regimen
n=12 participants at risk
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Ixazomib: Cycle 1:
Ixazomib: 4mg/day 1, 8, 15
Cycles 2-6:
Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Cyclophosphamide: Cycle 1:
Cyclophosphamide: 50 mg/day continuous daily
Cycles 2-6:
Cyclophosphamide: 50 mg/day continuous daily
Dexamethasone: Cycle 1:
Dexamethasone: 20 mg/day 1, 8, 15
Cycles 2-6:
Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
|
|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
Other adverse events
| Measure |
Ixazomib Regimen
n=12 participants at risk
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Ixazomib: Cycle 1:
Ixazomib: 4mg/day 1, 8, 15
Cycles 2-6:
Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
Maintenance:
Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Cyclophosphamide: Cycle 1:
Cyclophosphamide: 50 mg/day continuous daily
Cycles 2-6:
Cyclophosphamide: 50 mg/day continuous daily
Dexamethasone: Cycle 1:
Dexamethasone: 20 mg/day 1, 8, 15
Cycles 2-6:
Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
9/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Eye disorders
Eye disorders, other
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Dental caries
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Mucositis
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Gastrointestinal disorders
Vomit
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Chills
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Edema
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Fatigue
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Fever
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Flu-like symptoms
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
General disorders
Pain
|
58.3%
7/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Infections and infestations
Infection and infestations, other
|
50.0%
6/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Infections and infestations
Thrush
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Blood bicarbonate decreased
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Creatinine increased
|
50.0%
6/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Ejection fraction decreased
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Lymphocyte count decreased
|
83.3%
10/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Neutrophil count decreased
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Platelet count decreased
|
91.7%
11/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Weight gain
|
50.0%
6/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
Weight loss
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Investigations
White blood cell decreased
|
66.7%
8/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.7%
5/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Obesity
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm benign, other
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Nervous system disorders
Dizziness
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Nervous system disorders
Paresthesia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
58.3%
7/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Psychiatric disorders
Insomnia
|
50.0%
6/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Renal and urinary disorders
Bladder pressure
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Renal and urinary disorders
Hematuria
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Renal and urinary disorders
Urinary retention
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Reproductive system and breast disorders
Testicular pain
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
83.3%
10/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Vascular disorders
Flushing
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Vascular disorders
Hypotension
|
25.0%
3/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
33.3%
4/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
2/12 • All adverse events and special reporting situations were reported from the time a signed and dated ICF is obtained until 30 days after the last dose of drug, up to 25 months, or until the subject withdraws consent from study participation (declines participation) or at the time patient becomes a screen failure, whichever occurs first, an average of 2 years.
|
Additional Information
John Reagan, MD
Brown University Oncology Research Group
Phone: 401-863-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place