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NCT02726581 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to approximately 64 months

What was measured

The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria. sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h. PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.

Analysis population: All randomized participants 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-Pd75
Arm B: Pd71

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: N-Pd48.0Not reported36.359.8Not reported
Arm B: Pd54.9Not reported42.766.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.46
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    0.76
Complete source fields
analyses
  1. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.46
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    0.76
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.3
        upper Limit
        59.8
        value
        48.0
      2. group Id
        OG001
        lower Limit
        42.7
        upper Limit
        66.8
        value
        54.9
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      71
    units
    Participants
description
The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria. sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h. PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
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
NUMBER
population Description
All randomized participants 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 up to approximately 64 months
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice