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NCT01602224 · OUTCOME

Time to Next Treatment (TNT)

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 Initiation of New Cancer Treatment or Death From Any Cause (18 Months)

What was measured

TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy.

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+Bortezomib10.1Not reported7.011.9Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib9.9Not reported6.814.8Not reported
Placebo Comparator: Placebo + Dexamethasone + Bortezomib11.7Not reported7.817.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        11.9
        value
        10.1
      2. group Id
        OG001
        lower Limit
        6.8
        upper Limit
        14.8
        value
        9.9
      3. group Id
        OG002
        lower Limit
        7.8
        upper Limit
        17.5
        value
        11.7
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      74
    3. group Id
      OG002
      value
      72
    units
    Participants
description
TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy.
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 Initiation of New Cancer Treatment or Death From Any Cause (18 Months)
title
Time to Next Treatment (TNT)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice