Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma · Source last updated 2020-11-06
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
What was measured
Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events.
An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment.
A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:
* fatal
* life threatening
* requires in-patient hospitalization or prolongation of existing hospitalization
* results in persistent or significant disability/incapacity
* congenital anomaly/birth defect
* other medically important serious event
The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
Analysis population: All participants who received at least 1 dose of study drug (safety analysis set).
Groups in this outcome
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
10
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
12
RRMM Dose-expansion: Carfilzomib 70 mg/m²
34
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
9
NDMM Dose-expansion: Carfilzomib 70 mg/m²
9
NDMM Dose-expansion: Carfilzomib 56 mg/m²
33
Reported measurements
Any adverse event (AE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
10
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
12
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
34
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
9
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
9
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
33
Not reported
Not reported
Not reported
Not reported
AE Grade ≥ 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
7
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
9
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
23
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
6
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
21
Not reported
Not reported
Not reported
Not reported
Serious adverse events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
4
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
10
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
3
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
3
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
11
Not reported
Not reported
Not reported
Not reported
AEs leading to discontinuation of carfilzomib
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
AEs leading to discontinuation of lenalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
2
Not reported
Not reported
Not reported
Not reported
AEs leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
2
Not reported
Not reported
Not reported
Not reported
Fatal adverse events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
0
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
0
Not reported
Not reported
Not reported
Not reported
Treatment-related adverse events (TRAE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
9
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
11
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
30
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
9
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
9
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
32
Not reported
Not reported
Not reported
Not reported
Treatment-related AEs Grade ≥ 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
6
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
8
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
18
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
18
Not reported
Not reported
Not reported
Not reported
Treatment-related serious adverse events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
6
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
1
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
3
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
8
Not reported
Not reported
Not reported
Not reported
TRAEs leading to discontinuation of carfilzomib
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
TRAEs leading to discontinuation of lenalidomide
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
2
Not reported
Not reported
Not reported
Not reported
TRAEs leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
1
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
5
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
2
Not reported
Not reported
Not reported
Not reported
Treatment-related fatal adverse events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
0
Not reported
Not reported
Not reported
Not reported
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
RRMM Dose-expansion: Carfilzomib 70 mg/m²
2
Not reported
Not reported
Not reported
Not reported
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 70 mg/m²
0
Not reported
Not reported
Not reported
Not reported
NDMM Dose-expansion: Carfilzomib 56 mg/m²
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
12
group Id
OG002
value
34
group Id
OG003
value
9
group Id
OG004
value
9
group Id
OG005
value
33
title
Any adverse event (AE)
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
9
group Id
OG002
value
23
group Id
OG003
value
5
group Id
OG004
value
6
group Id
OG005
value
21
title
AE Grade ≥ 3
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
10
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
11
title
Serious adverse events
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
1
title
AEs leading to discontinuation of carfilzomib
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
2
title
AEs leading to discontinuation of lenalidomide
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
2
title
AEs leading to discontinuation of dexamethasone
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Fatal adverse events
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
11
group Id
OG002
value
30
group Id
OG003
value
9
group Id
OG004
value
9
group Id
OG005
value
32
title
Treatment-related adverse events (TRAE)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
8
group Id
OG002
value
18
group Id
OG003
value
5
group Id
OG004
value
5
group Id
OG005
value
18
title
Treatment-related AEs Grade ≥ 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
1
group Id
OG004
value
3
group Id
OG005
value
8
title
Treatment-related serious adverse events
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
1
title
TRAEs leading to discontinuation of carfilzomib
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
2
title
TRAEs leading to discontinuation of lenalidomide
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
12
group Id
OG002
value
34
group Id
OG003
value
9
group Id
OG004
value
9
group Id
OG005
value
33
units
Participants
description
Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events.
An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment.
A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:
* fatal
* life threatening
* requires in-patient hospitalization or prolongation of existing hospitalization
* results in persistent or significant disability/incapacity
* congenital anomaly/birth defect
* other medically important serious event
The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
groups
description
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
OG000
title
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
description
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
OG001
title
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
description
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
OG002
title
RRMM Dose-expansion: Carfilzomib 70 mg/m²
description
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
OG003
title
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
description
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
OG004
title
NDMM Dose-expansion: Carfilzomib 70 mg/m²
description
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
id
OG005
title
NDMM Dose-expansion: Carfilzomib 56 mg/m²
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least 1 dose of study drug (safety analysis set).
reporting Status
POSTED
time Frame
From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
Triangle