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NCT02969837 · OUTCOME

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

GroupSource count
Elo-KRd Regimen46

Reported measurements

Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen11Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen9Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen8Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen4Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen33Not reportedNot reportedNot reportedNot reported
Infection-Upper respiratory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen19Not reportedNot reportedNot reportedNot reported
Infection-Non-pulmonary
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen22Not reportedNot reportedNot reportedNot reported
Infection-Lung
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen7Not reportedNot reportedNot reportedNot reported
Infection-Bronchial
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen2Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen29Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen20Not reportedNot reportedNot reportedNot reported
Peripheral neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen19Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen16Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen14Not reportedNot reportedNot reportedNot reported
Cardia events, any
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen12Not reportedNot reportedNot reportedNot reported
Electrolyte imbalances, any
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen12Not reportedNot reportedNot reportedNot reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen11Not reportedNot reportedNot reportedNot reported
Rash
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen7Not reportedNot reportedNot reportedNot reported
Thromboembolic events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen5Not reportedNot reportedNot reportedNot reported
Infusion reactions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen5Not reportedNot reportedNot reportedNot reported
Acute kidney injury
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elo-KRd Regimen5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Thrombocytopenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Lymphopenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    title
    Fatigue
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Infection-Upper respiratory
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Infection-Non-pulmonary
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Infection-Lung
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Infection-Bronchial
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Diarrhea
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Dyspnea
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Peripheral neuropathy
denoms
  1. counts
    1. 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
  1. 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
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice