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NCT02903381 · OUTCOME

Duration of Response Probability at 2-years

A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma · Source last updated 2023-06-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
probability
Interval / dispersion
90% Confidence Interval
Time frame
time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, up to 24 months post initiation of therapy.

What was measured

Kaplan-Meier method, duration of response probability in patients with partial response or better. Events defined as confirmed progression or death from any cause

Analysis population: 7 of 8 patients achieved a confirmed objective response and are included in duration of response analysis

Groups in this outcome

Nivolumab, Lenalidomide, Dexamethasone

* A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months. Nivolumab: Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and Lenalidomide: Oral, predetermined dosage, Days 1-21 of cycle 1-12 Dexamethasone: Oral, Days 1, 8, 15 of cycle 1-6

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

Analysis denominator · Participants

GroupSource count
Nivolumab, Lenalidomide, Dexamethasone7

Reported measurements

Source class 1
Values in probability · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, Lenalidomide, Dexamethasone0.71Not reported0.481.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.48
        upper Limit
        1.0
        value
        0.71
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Kaplan-Meier method, duration of response probability in patients with partial response or better. Events defined as confirmed progression or death from any cause
dispersion Type
90% Confidence Interval
groups
  1. description
    * A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months. Nivolumab: Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and Lenalidomide: Oral, predetermined dosage, Days 1-21 of cycle 1-12 Dexamethasone: Oral, Days 1, 8, 15 of cycle 1-6
    id
    OG000
    title
    Nivolumab, Lenalidomide, Dexamethasone
param Type
NUMBER
population Description
7 of 8 patients achieved a confirmed objective response and are included in duration of response analysis
reporting Status
POSTED
time Frame
time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, up to 24 months post initiation of therapy.
title
Duration of Response Probability at 2-years
type
SECONDARY
unit Of Measure
probability

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

Preserved source evidence · Not medical advice