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NCT02272803 · OUTCOME

Progression Free Survival (PFS) Rate

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan · Source last updated 2022-06-22

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to the specified timepoints, up to 3 years

What was measured

PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints

Analysis population: All randomized participants

Groups in this outcome

Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1

Arm B: Lenalidomide + Dexamethasone

Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle

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

Analysis denominator · Participants

GroupSource count
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)40
Arm B: Lenalidomide + Dexamethasone42

Reported measurements

1 year
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)0.87Not reported0.720.95Not reported
Arm B: Lenalidomide + Dexamethasone0.89Not reported0.730.96Not reported
2 years
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)0.67Not reported0.490.80Not reported
Arm B: Lenalidomide + Dexamethasone0.60Not reported0.410.75Not reported
3 years
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)0.61Not reported0.420.75Not reported
Arm B: Lenalidomide + Dexamethasone0.56Not reported0.360.71Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        0.95
        value
        0.87
      2. group Id
        OG001
        lower Limit
        0.73
        upper Limit
        0.96
        value
        0.89
    title
    1 year
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.49
        upper Limit
        0.80
        value
        0.67
      2. group Id
        OG001
        lower Limit
        0.41
        upper Limit
        0.75
        value
        0.60
    title
    2 years
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.42
        upper Limit
        0.75
        value
        0.61
      2. group Id
        OG001
        lower Limit
        0.36
        upper Limit
        0.71
        value
        0.56
    title
    3 years
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      42
    units
    Participants
description
PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1
    id
    OG000
    title
    Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
  2. description
    Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
    id
    OG001
    title
    Arm B: Lenalidomide + Dexamethasone
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization up to the specified timepoints, up to 3 years
title
Progression Free Survival (PFS) Rate
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice