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NCT02168101 · OUTCOME

Median Overall Survival (OS) at 2 Years Post-allogeneic Stem Cell Transplant (ASCT)

Determining the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma · Source last updated 2020-02-27

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
every 8 weeks for approximately 24 weeks after ASCT, then every 3 months thereafter for 2 years.

What was measured

Overall survival is measured as the interval from first study treatment until date of death, or date last known alive.

Analysis population: All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.

Groups in this outcome

MLN9708 Combined Dose Escalation

Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of either 2.3, 3, or 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 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
MLN9708 Combined Dose Escalation8

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MLN9708 Combined Dose EscalationNANot reported6.1NANot reached at this time.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not reached at this time.
        group Id
        OG000
        lower Limit
        6.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Overall survival is measured as the interval from first study treatment until date of death, or date last known alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of either 2.3, 3, or 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
    id
    OG000
    title
    MLN9708 Combined Dose Escalation
param Type
MEDIAN
population Description
All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.
reporting Status
POSTED
time Frame
every 8 weeks for approximately 24 weeks after ASCT, then every 3 months thereafter for 2 years.
title
Median Overall Survival (OS) at 2 Years Post-allogeneic Stem Cell Transplant (ASCT)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice