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NCT01955434 · OUTCOME

Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161

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
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Up to 1 year

What was measured

The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+\<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to \<200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method.

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)25

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)0Not reported013.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        13.7
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+\<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to \<200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method.
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
NUMBER
reporting Status
POSTED
time Frame
Up to 1 year
title
Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice