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NCT02516696 · OUTCOME

Overall Response Rate

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Capture the number of subjects who demonstrate a complete or partial response to treatment with BiRD regimen, as compared to Rd. Complete and partial responses are defined by the International Myeloma Working Group Criteria.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BiRD Treatment Regimen7Not reportedNot reportedNot reportedNot reported
Rd Treatment Regimen4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Capture the number of subjects who demonstrate a complete or partial response to treatment with BiRD regimen, as compared to Rd. Complete and partial responses are defined by the International Myeloma Working Group Criteria.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice