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NCT01955434 · OUTCOME

Event-free Survival

SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-09-10

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
From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 year

What was measured

The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.

Analysis population: Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.

Groups in this outcome

Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)

Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)23

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)10.0Not reported4.624.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.6
        upper Limit
        24.4
        value
        10.0
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
param Type
MEDIAN
population Description
Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.
reporting Status
POSTED
time Frame
From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 year
title
Event-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice