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NCT01706666 · OUTCOME

Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months

Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant · Source last updated 2018-09-17

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
24 months

What was measured

Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.

Groups in this outcome

Arm A

Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

Arm B

Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

Arm C

Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.

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

Analysis denominator · Participants

GroupSource count
Arm A1
Arm B1
Arm C1

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A100Not reportedNot reportedNot reportedNot reported
Arm B0Not reportedNot reportedNot reportedNot reported
Arm C100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.
groups
  1. description
    Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
    id
    OG000
    title
    Arm A
  2. description
    Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
    id
    OG001
    title
    Arm B
  3. description
    Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
    id
    OG002
    title
    Arm C
param Type
NUMBER
reporting Status
POSTED
time Frame
24 months
title
Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice