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NCT02516696 · OUTCOME

Number of Months to Progression-Free Survival 2

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
approximately 5 years

What was measured

Time from study entry until 2nd instance of disease progression. Progression is determined by the International Myeloma Working Group Criteria. Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.

Analysis population: Data not collected due to early trial termination due to low accrual.

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 Regimen0
Rd Treatment Regimen0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Time from study entry until 2nd instance of disease progression. Progression is determined by the International Myeloma Working Group Criteria. Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
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
population Description
Data not collected due to early trial termination due to low accrual.
reporting Status
POSTED
time Frame
approximately 5 years
title
Number of Months to Progression-Free Survival 2
type
SECONDARY

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

Preserved source evidence · Not medical advice