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NCT01602224 · OUTCOME

Time to Progression (TTP)

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 Objective Disease Progression or Death (assessed up to 9 months)

What was measured

Time to progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes.

Analysis population: All randomized participants, with 79 participants censored.

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+Bortezomib6.6Not reported5.99.3Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib8.2Not reported6.411.2Not reported
Placebo Comparator: Placebo + Dexamethasone + Bortezomib8.1Not reported6.99.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.9
        upper Limit
        9.3
        value
        6.6
      2. group Id
        OG001
        lower Limit
        6.4
        upper Limit
        11.2
        value
        8.2
      3. group Id
        OG002
        lower Limit
        6.9
        upper Limit
        9.5
        value
        8.1
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 progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes.
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, with 79 participants censored.
reporting Status
POSTED
time Frame
Baseline to Objective Disease Progression or Death (assessed up to 9 months)
title
Time to Progression (TTP)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice