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NCT00522392 · OUTCOME

Overall Survival (OS)

Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone · Source last updated 2015-06-26

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years

What was measured

Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.

Analysis population: All randomized patients

Groups in this outcome

Arm A (VRD)

Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. bortezomib: Given IV lenalidomide: Given PO dexamethasone: Given PO

Arm B (VD)

Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. bortezomib: Given IV dexamethasone: Given PO

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 (VRD)23
Arm B (VD)25

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (VRD)64.0Not reported50.265.2Not reported
Arm B (VD)NANot reportedNANAMedian overall survival was not reached in Arm B.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Description
    Stratified log-rank test was used to compare overall survival between the two arms.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.48
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Stratified log-rank test was used to compare overall survival between the two arms.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.48
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.2
        upper Limit
        65.2
        value
        64.0
      2. comment
        Median overall survival was not reached in Arm B.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin. bortezomib: Given IV lenalidomide: Given PO dexamethasone: Given PO
    id
    OG000
    title
    Arm A (VRD)
  2. description
    Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. bortezomib: Given IV dexamethasone: Given PO
    id
    OG001
    title
    Arm B (VD)
param Type
MEDIAN
population Description
All randomized patients
reporting Status
POSTED
time Frame
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice