Number of Participants With Adverse Events of Elotuzumab in Combination With KRd
Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma · Source last updated 2026-01-16
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
AEs were recorded from the day of signed consent through 30 days after the last does of Elo-KRd or initiation of new therapy, an average of 2 years.
What was measured
AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Groups in this outcome
Elo-KRd Regimen
Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression.
Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15
Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond
Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles.
Dexamethasone: Dexamethasone will be given as follows:
Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
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
Elo-KRd Regimen
46
Reported measurements
Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
11
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
9
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
8
Not reported
Not reported
Not reported
Not reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
4
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
33
Not reported
Not reported
Not reported
Not reported
Infection-Upper respiratory
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
19
Not reported
Not reported
Not reported
Not reported
Infection-Non-pulmonary
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
22
Not reported
Not reported
Not reported
Not reported
Infection-Lung
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
7
Not reported
Not reported
Not reported
Not reported
Infection-Bronchial
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
2
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
29
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
20
Not reported
Not reported
Not reported
Not reported
Peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
19
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
16
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
14
Not reported
Not reported
Not reported
Not reported
Cardia events, any
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
12
Not reported
Not reported
Not reported
Not reported
Electrolyte imbalances, any
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
12
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
11
Not reported
Not reported
Not reported
Not reported
Rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
7
Not reported
Not reported
Not reported
Not reported
Thromboembolic events
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
5
Not reported
Not reported
Not reported
Not reported
Infusion reactions
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
5
Not reported
Not reported
Not reported
Not reported
Acute kidney injury
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Elo-KRd Regimen
5
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
11
title
Anemia
categories
measurements
group Id
OG000
value
9
title
Neutropenia
categories
measurements
group Id
OG000
value
8
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
4
title
Lymphopenia
categories
measurements
group Id
OG000
value
33
title
Fatigue
categories
measurements
group Id
OG000
value
19
title
Infection-Upper respiratory
categories
measurements
group Id
OG000
value
22
title
Infection-Non-pulmonary
categories
measurements
group Id
OG000
value
7
title
Infection-Lung
categories
measurements
group Id
OG000
value
2
title
Infection-Bronchial
categories
measurements
group Id
OG000
value
29
title
Diarrhea
categories
measurements
group Id
OG000
value
20
title
Dyspnea
categories
measurements
group Id
OG000
value
19
title
Peripheral neuropathy
denoms
counts
group Id
OG000
value
46
units
Participants
description
AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
groups
description
Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression.
Elotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15
Carfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond
Lenalidomide: Lenalidomide will be given on days 1-21 for all cycles.
Dexamethasone: Dexamethasone will be given as follows:
Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
id
OG000
title
Elo-KRd Regimen
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
AEs were recorded from the day of signed consent through 30 days after the last does of Elo-KRd or initiation of new therapy, an average of 2 years.
title
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd