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NCT02516696 · OUTCOME

Overall Survival

BiRd vs. Rd as Initial Therapy in Multiple Myeloma · Source last updated 2023-06-05

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
4 years

What was measured

Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.

Groups in this outcome

BiRD Treatment Regimen

Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.

Rd Treatment Regimen

Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.

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

Analysis denominator · Participants

GroupSource count
BiRD Treatment Regimen7
Rd Treatment Regimen5

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BiRD Treatment RegimenNANot reported906NAMedian overall survival was not reached for patients in the BiRd arm (95% CI: 906-NA).
Rd Treatment Regimen1014Not reported821NAParticipants were still alive at the time of study closure.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median overall survival was not reached for patients in the BiRd arm (95% CI: 906-NA).
        group Id
        OG000
        lower Limit
        906
        upper Limit
        NA
        value
        NA
      2. comment
        Participants were still alive at the time of study closure.
        group Id
        OG001
        lower Limit
        821
        upper Limit
        NA
        value
        1014
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
    id
    OG000
    title
    BiRD Treatment Regimen
  2. description
    Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
    id
    OG001
    title
    Rd Treatment Regimen
param Type
MEDIAN
reporting Status
POSTED
time Frame
4 years
title
Overall Survival
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice