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NCT04119336 · OUTCOME

Objective Response Rate (ORR)

Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma · Source last updated 2023-08-21

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
Not reported
Time frame
up to 8 months

What was measured

ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below. * CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow * Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry * PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to \<200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30% * Very Good PR (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/24 h

Groups in this outcome

Nivolumab and Ixazomib

\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.

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 and Ixazomib2

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab and Ixazomib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below. * CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow * Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry * PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to \<200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30% * Very Good PR (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/24 h
groups
  1. description
    \- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
    id
    OG000
    title
    Nivolumab and Ixazomib
param Type
NUMBER
reporting Status
POSTED
time Frame
up to 8 months
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice