NCT03201250 · ADVERSE EVENTS

Adverse events

Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple Myeloma · Source last updated 2023-09-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All patients will be closely followed for toxicity from the time of informed consent until 30 days after last administration of study medication upto approximately 2 years.
Other-event reporting threshold: 5%

Since no subjects were enrolled into the 60 mg dose level for the study number of participants at risk for SAEs, All-Cause Mortality and Other AEs is zero for the dose level +1 = 60mg Arm/Group.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level -1 = 20 mg Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Carfilzomib: carfilzomib will be administered intravenously over 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. Dexamethasone: dexamethasone will be administered at 40 mg orally or intravenously on days 1, 8,15 and 22 of each 28-day cycle (for patient age ≥ 75, acceptable to be given as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, 23) Cabozantinib: Cabozantinib: Phase I: Level -1 = 20 mg PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)	0 / 5	3 / 5	1 / 5
Dose Level 0 = 40 mg Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Carfilzomib: carfilzomib will be administered intravenously over 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. Dexamethasone: dexamethasone will be administered at 40 mg orally or intravenously on days 1, 8,15 and 22 of each 28-day cycle (for patient age ≥ 75, acceptable to be given as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, 23) Cabozantinib: Cabozantinib: Phase I: Level 0 = 40 mg PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)	2 / 3	3 / 3	0 / 3
Dose Level +1= 60 mg Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Carfilzomib: carfilzomib will be administered intravenously over 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. Dexamethasone: dexamethasone will be administered at 40 mg orally or intravenously on days 1, 8,15 and 22 of each 28-day cycle (for patient age ≥ 75, acceptable to be given as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, 23) Cabozantinib: Cabozantinib: Phase I: Level +1 = 60 mg, PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Dose Level -1 = 20 mg · EG001: Dose Level 0 = 40 mg · EG002: Dose Level +1= 60 mg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
Other - Bacteremia infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
hematuria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
Non-cardiac chest pain

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num At Risk
0
term
hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num At Risk
0
term
hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
4
group Id
EG002
num At Risk
0
term
platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
cardiomyopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
group Id
EG002
num At Risk
0
term
alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
group Id
EG002
num At Risk
0
term
aspartate aminotransferase increased

Complete source fields

description

Since no subjects were enrolled into the 60 mg dose level for the study number of participants at risk for SAEs, All-Cause Mortality and Other AEs is zero for the dose level +1 = 60mg Arm/Group.

event Groups

deaths Num Affected
1
deaths Num At Risk
5
description
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Carfilzomib: carfilzomib will be administered intravenously over 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. Dexamethasone: dexamethasone will be administered at 40 mg orally or intravenously on days 1, 8,15 and 22 of each 28-day cycle (for patient age ≥ 75, acceptable to be given as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, 23) Cabozantinib: Cabozantinib: Phase I: Level -1 = 20 mg PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
id
EG000
other Num Affected
3
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Dose Level -1 = 20 mg
deaths Num Affected
0
deaths Num At Risk
3
description
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Carfilzomib: carfilzomib will be administered intravenously over 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. Dexamethasone: dexamethasone will be administered at 40 mg orally or intravenously on days 1, 8,15 and 22 of each 28-day cycle (for patient age ≥ 75, acceptable to be given as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, 23) Cabozantinib: Cabozantinib: Phase I: Level 0 = 40 mg PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Level 0 = 40 mg
deaths Num Affected
0
deaths Num At Risk
0
description
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Carfilzomib: carfilzomib will be administered intravenously over 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17 to 28). Each 28-day period is considered one treatment cycle. Dexamethasone: dexamethasone will be administered at 40 mg orally or intravenously on days 1, 8,15 and 22 of each 28-day cycle (for patient age ≥ 75, acceptable to be given as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, 23) Cabozantinib: Cabozantinib: Phase I: Level +1 = 60 mg, PO daily on days 1-28 Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level +1= 60 mg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num At Risk
0
term
hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num At Risk
0
term
hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
4
group Id
EG002
num At Risk
0
term
platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
cardiomyopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
group Id
EG002
num At Risk
0
term
alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
group Id
EG002
num At Risk
0
term
aspartate aminotransferase increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
Other - Bacteremia infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
hematuria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num At Risk
0
term
Non-cardiac chest pain

time Frame

All patients will be closely followed for toxicity from the time of informed consent until 30 days after last administration of study medication upto approximately 2 years.

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Preserved source evidence · Not medical advice