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NCT01602224 · OUTCOME

Time to First Skeletal-Related Event (SRE)

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM) · Source last updated 2019-10-08

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
Baseline to Date of First Skeletal Related Event (assessed up to 19 months)

What was measured

Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE.

Analysis population: All randomized participants.

Groups in this outcome

100 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

300 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

Placebo Comparator: Placebo + Dexamethasone + Bortezomib

Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

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

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib74
300 mg Tabalumab+Dexamethasone+Bortezomib74
Placebo Comparator: Placebo + Dexamethasone + Bortezomib72

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+BortezomibNANot reportedNANAMedians were not reached for timeframe
300 mg Tabalumab+Dexamethasone+BortezomibNANot reported19.8NAMedians were not reached for timeframe
Placebo Comparator: Placebo + Dexamethasone + BortezomibNANot reportedNANAMedians were not reached for timeframe
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Medians were not reached for timeframe
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Medians were not reached for timeframe
        group Id
        OG001
        lower Limit
        19.8
        upper Limit
        NA
        value
        NA
      3. comment
        Medians were not reached for timeframe
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      74
    3. group Id
      OG002
      value
      72
    units
    Participants
description
Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG000
    title
    100 mg Tabalumab+Dexamethasone+Bortezomib
  2. description
    Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG001
    title
    300 mg Tabalumab+Dexamethasone+Bortezomib
  3. description
    Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG002
    title
    Placebo Comparator: Placebo + Dexamethasone + Bortezomib
param Type
MEDIAN
population Description
All randomized participants.
reporting Status
POSTED
time Frame
Baseline to Date of First Skeletal Related Event (assessed up to 19 months)
title
Time to First Skeletal-Related Event (SRE)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice