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NCT02903381 · OUTCOME

Objective Response Percent

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
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
2 Years

What was measured

The percent of patients with objective response defined as achieving a partial response or better according to the modified International Myeloma Working Group (IMWG) criteria

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, Dexamethasone8

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab, Lenalidomide, Dexamethasone87.5Not reported52.999.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.9
        upper Limit
        99.4
        value
        87.5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The percent of patients with objective response defined as achieving a partial response or better according to the modified International Myeloma Working Group (IMWG) criteria
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
reporting Status
POSTED
time Frame
2 Years
title
Objective Response Percent
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice