Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01441973 · OUTCOME

Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma · Source last updated 2018-01-23

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

Measure
NUMBER
Unit
% chg from BL in M pro/% chg CD56^dim cs
Interval / dispersion
95% Confidence Interval
Time frame
From day of last patient, first dose to 6 months

What was measured

Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)

Analysis population: All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).

Groups in this outcome

Elotuzumab, 20 mg/kg

Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.

Elotuzumab, 10 mg/kg

Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.

Elotuzumab, All Dosages

All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms

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, 20 mg/kg13
Elotuzumab, 10 mg/kg12
Elotuzumab, All Dosages31

Reported measurements

Source class 1
Values in % chg from BL in M pro/% chg CD56^dim cs · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Elotuzumab, 20 mg/kg-2.562Not reported-5.4390.316Not reported
Elotuzumab, 10 mg/kg2.464Not reported0.0864.842Not reported
Elotuzumab, All Dosages0.274Not reported-1.7222.270Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.439
        upper Limit
        0.316
        value
        -2.562
      2. group Id
        OG001
        lower Limit
        0.086
        upper Limit
        4.842
        value
        2.464
      3. group Id
        OG002
        lower Limit
        -1.722
        upper Limit
        2.270
        value
        0.274
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      31
    units
    Participants
description
Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
    id
    OG000
    title
    Elotuzumab, 20 mg/kg
  2. description
    Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
    id
    OG001
    title
    Elotuzumab, 10 mg/kg
  3. description
    All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
    id
    OG002
    title
    Elotuzumab, All Dosages
param Type
NUMBER
population Description
All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).
reporting Status
POSTED
time Frame
From day of last patient, first dose to 6 months
title
Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
type
PRIMARY
unit Of Measure
% chg from BL in M pro/% chg CD56^dim cs

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

Preserved source evidence · Not medical advice