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NCT00833560 · OUTCOME

Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)

A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy · Source last updated 2014-11-21

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 Day 63

What was measured

Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible

Analysis population: Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).

Groups in this outcome

Cyclophosphamide + Bortezomib + Dexamethasone

Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles

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

Analysis denominator · Participants

GroupSource count
Cyclophosphamide + Bortezomib + Dexamethasone334

Reported measurements

13q- (n=112)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide + Bortezomib + Dexamethasone90.2Not reportedNot reportedNot reportedNot reported
t (4;14) (n=38)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide + Bortezomib + Dexamethasone89.5Not reportedNot reportedNot reportedNot reported
17p- (n=31)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide + Bortezomib + Dexamethasone74.2Not reportedNot reportedNot reportedNot reported
Other (n=104)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide + Bortezomib + Dexamethasone87.5Not reportedNot reportedNot reportedNot reported
No changes (n=102)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide + Bortezomib + Dexamethasone84.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        90.2
    title
    13q- (n=112)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        89.5
    title
    t (4;14) (n=38)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        74.2
    title
    17p- (n=31)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        87.5
    title
    Other (n=104)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        84.3
    title
    No changes (n=102)
denoms
  1. counts
    1. group Id
      OG000
      value
      334
    units
    Participants
description
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible
groups
  1. description
    Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
    id
    OG000
    title
    Cyclophosphamide + Bortezomib + Dexamethasone
param Type
NUMBER
population Description
Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker).
reporting Status
POSTED
time Frame
Up to Day 63
title
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice