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NCT00609167 · OUTCOME

Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles

Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2011-05-17

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
4 cycles

What was measured

Response that was confirmed on 2 consecutive evaluations after 8 months of treatment. CR, nCR and VGPR as defined in the primary outcome. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.

Analysis population: Participants who received 4 cycles of treatment were analyzed.

Groups in this outcome

CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20

CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22

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

Analysis denominator · Participants

GroupSource count
CyBorD (Bortezomib 1.3mg/m^2)33
CyBorD (Bortezomib 1.5mg/m^2)30

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CyBorD (Bortezomib 1.3mg/m^2)29Not reportedNot reportedNot reportedNot reported
CyBorD (Bortezomib 1.5mg/m^2)28Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Response that was confirmed on 2 consecutive evaluations after 8 months of treatment. CR, nCR and VGPR as defined in the primary outcome. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
groups
  1. description
    Bortezomib 1.3mg/m\^2 by IV days 1, 4, 8 \& 11 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
    id
    OG000
    title
    CyBorD (Bortezomib 1.3mg/m^2)
  2. description
    Bortezomib 1.5mg/m\^2 by IV days 1, 8, 15 \& 22 Cyclophosphamide 300mg/m\^2 PO days 1, 8, 15 \& 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 \& 22
    id
    OG001
    title
    CyBorD (Bortezomib 1.5mg/m^2)
param Type
NUMBER
population Description
Participants who received 4 cycles of treatment were analyzed.
reporting Status
POSTED
time Frame
4 cycles
title
Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice