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NCT02726581 · OUTCOME

Duration of Objective Response (DOR)

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma · Source last updated 2023-03-27

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
From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)

What was measured

The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.

Analysis population: All responders (sCR, CR, VGPR, or PR) in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.

Groups in this outcome

Arm A: N-Pd

Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Arm B: Pd

Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

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

Analysis denominator · Participants

GroupSource count
Arm A: N-Pd36
Arm B: Pd39

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: N-Pd8.51Not reported6.4713.83Not reported
Arm B: Pd6.47Not reported5.5511.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.47
        upper Limit
        13.83
        value
        8.51
      2. group Id
        OG001
        lower Limit
        5.55
        upper Limit
        11.07
        value
        6.47
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      39
    units
    Participants
description
The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    OG000
    title
    Arm A: N-Pd
  2. description
    Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    OG001
    title
    Arm B: Pd
param Type
MEDIAN
population Description
All responders (sCR, CR, VGPR, or PR) in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
reporting Status
POSTED
time Frame
From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)
title
Duration of Objective Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice