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NCT00609167 · OUTCOME

Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment

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
After 4 months of treatment

What was measured

Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow.

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)20Not reportedNot reportedNot reportedNot reported
CyBorD (Bortezomib 1.5mg/m^2)18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        18
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 during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow.
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
reporting Status
POSTED
time Frame
After 4 months of treatment
title
Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice