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NCT02002598 · OUTCOME

Overall Response Rate (ORR)

Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma · Source last updated 2024-09-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

ORR defined as the number of participants demonstrating complete response or partial response. Complete response defined as complete disappearance of an M-protein and no evidence of MM in the bone marrow. Partial response defined as ≥50% reduction in the level of the serum monoclonal paraprotein, reduction in 24-hour M-protein either by greater than or equal to 90% or to \<200 mg, ≥50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination), no increase in the number or size of lytic bone lesions.

Groups in this outcome

CFZ With Bendamustine and Dexamethasone

First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg. Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.

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

Analysis denominator · Participants

GroupSource count
CFZ With Bendamustine and Dexamethasone19

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CFZ With Bendamustine and Dexamethasone19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
ORR defined as the number of participants demonstrating complete response or partial response. Complete response defined as complete disappearance of an M-protein and no evidence of MM in the bone marrow. Partial response defined as ≥50% reduction in the level of the serum monoclonal paraprotein, reduction in 24-hour M-protein either by greater than or equal to 90% or to \<200 mg, ≥50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination), no increase in the number or size of lytic bone lesions.
groups
  1. description
    First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg. Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.
    id
    OG000
    title
    CFZ With Bendamustine and Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice