Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00742560 · OUTCOME

Mean Serum Concentrations of Elotuzumab During Cycle 1

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma · Source last updated 2018-01-10

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)

What was measured

Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.

Analysis population: Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.

Groups in this outcome

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone39
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone58

Reported measurements

Day 1: 0 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone39
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone58
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone0.000.00Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone0.000.00Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone0.000.00Not reportedNot reportedNot reported
Day 1: 0.5 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone39
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone57
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone78.4821.33Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone217.9099.31Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone434.20202.74Not reportedNot reportedNot reported
Day 1: 2 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone0
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone36
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone43
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone213.3191.30Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone388.58112.94Not reportedNot reportedNot reported
Day 1: 4 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone12
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone85.5623.54Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone251.3431.92Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone525.98188.46Not reportedNot reportedNot reported
Day 8: 0 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone37
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone55
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone32.448.91Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone92.4761.16Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone168.5556.43Not reportedNot reportedNot reported
Day 8: 0.5 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone22
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone44
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone133.3740.87Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone281.53117.35Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone593.80192.70Not reportedNot reportedNot reported
Day 8: 2 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone0
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone12
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone9
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone268.35107.44Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone520.97207.28Not reportedNot reportedNot reported
Day 15: 0 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone37
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone58
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone49.8428.28Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone111.1156.36Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone298.82231.17Not reportedNot reportedNot reported
Day 15: 0.5 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone36
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone55
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone140.0932.28Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone282.29100.29Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone661.91251.08Not reportedNot reportedNot reported
Day 22: 0 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone38
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone54
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone61.9353.66Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone135.92106.83Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone308.02144.61Not reportedNot reportedNot reported
Day 22: 0.5 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone38
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone54
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone168.6159.31Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone310.03165.14Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone699.70230.41Not reportedNot reportedNot reported
Day 22: 2 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone1
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone35
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone40
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone268.53NANot reportedNot reportedThe estimated standard deviation of one sample is undefined
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone298.85114.35Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone704.48234.98Not reportedNot reportedNot reported
Day 22: 4 hours

Analysis denominator · Participants

GroupSource count
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone2
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone3
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone10
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone128.9442.04Not reportedNot reportedNot reported
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone538.88195.35Not reportedNot reportedNot reported
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone981.16280.28Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        0.00
      2. group Id
        OG001
        spread
        0.00
        value
        0.00
      3. group Id
        OG002
        spread
        0.00
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        58
      units
      Participants
    title
    Day 1: 0 hours
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.33
        value
        78.48
      2. group Id
        OG001
        spread
        99.31
        value
        217.90
      3. group Id
        OG002
        spread
        202.74
        value
        434.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        57
      units
      Participants
    title
    Day 1: 0.5 hours
  3. categories
    1. measurements
      1. group Id
        OG001
        spread
        91.30
        value
        213.31
      2. group Id
        OG002
        spread
        112.94
        value
        388.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        43
      units
      Participants
    title
    Day 1: 2 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.54
        value
        85.56
      2. group Id
        OG001
        spread
        31.92
        value
        251.34
      3. group Id
        OG002
        spread
        188.46
        value
        525.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Day 1: 4 hours
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.91
        value
        32.44
      2. group Id
        OG001
        spread
        61.16
        value
        92.47
      3. group Id
        OG002
        spread
        56.43
        value
        168.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        55
      units
      Participants
    title
    Day 8: 0 hours
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.87
        value
        133.37
      2. group Id
        OG001
        spread
        117.35
        value
        281.53
      3. group Id
        OG002
        spread
        192.70
        value
        593.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        44
      units
      Participants
    title
    Day 8: 0.5 hours
  7. categories
    1. measurements
      1. group Id
        OG001
        spread
        107.44
        value
        268.35
      2. group Id
        OG002
        spread
        207.28
        value
        520.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    Day 8: 2 hours
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.28
        value
        49.84
      2. group Id
        OG001
        spread
        56.36
        value
        111.11
      3. group Id
        OG002
        spread
        231.17
        value
        298.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        58
      units
      Participants
    title
    Day 15: 0 hours
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.28
        value
        140.09
      2. group Id
        OG001
        spread
        100.29
        value
        282.29
      3. group Id
        OG002
        spread
        251.08
        value
        661.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        55
      units
      Participants
    title
    Day 15: 0.5 hours
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.66
        value
        61.93
      2. group Id
        OG001
        spread
        106.83
        value
        135.92
      3. group Id
        OG002
        spread
        144.61
        value
        308.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        54
      units
      Participants
    title
    Day 22: 0 hours
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.31
        value
        168.61
      2. group Id
        OG001
        spread
        165.14
        value
        310.03
      3. group Id
        OG002
        spread
        230.41
        value
        699.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        54
      units
      Participants
    title
    Day 22: 0.5 hours
  12. categories
    1. measurements
      1. comment
        The estimated standard deviation of one sample is undefined
        group Id
        OG000
        spread
        NA
        value
        268.53
      2. group Id
        OG001
        spread
        114.35
        value
        298.85
      3. group Id
        OG002
        spread
        234.98
        value
        704.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        35
      3. group Id
        OG002
        value
        40
      units
      Participants
    title
    Day 22: 2 hours
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      58
    units
    Participants
description
Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.
dispersion Type
Standard Deviation
groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
    id
    OG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
    id
    OG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
    id
    OG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
param Type
MEAN
population Description
Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.
reporting Status
POSTED
time Frame
Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)
title
Mean Serum Concentrations of Elotuzumab During Cycle 1
type
SECONDARY
unit Of Measure
μg/mL

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

Preserved source evidence · Not medical advice