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NCT01160484 · OUTCOME

International Myeloma Working Group (IMWG) Response Criteria

Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma · Source last updated 2015-05-04

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
Up to 7.5 months (eight 28-day cycles)

What was measured

The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.

Analysis population: Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria \[complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)\]

Groups in this outcome

DVD-R Single Arm

40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.

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

Analysis denominator · Participants

GroupSource count
DVD-R Single Arm39

Reported measurements

CR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm8Not reportedNot reportedNot reportedNot reported
VGPR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm4Not reportedNot reportedNot reportedNot reported
PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm7Not reportedNot reportedNot reportedNot reported
Objective Response (CR+VGPR+PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm19Not reportedNot reportedNot reportedNot reported
MR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm14Not reportedNot reportedNot reportedNot reported
Clinical Benefit (CR+VGPR+PR+MR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm33Not reportedNot reportedNot reportedNot reported
Estable disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm4Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DVD-R Single Arm2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    PR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Objective Response (CR+VGPR+PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    MR
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    title
    Clinical Benefit (CR+VGPR+PR+MR)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Estable disease
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.
groups
  1. description
    40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
    id
    OG000
    title
    DVD-R Single Arm
param Type
NUMBER
population Description
Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria \[complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)\]
reporting Status
POSTED
time Frame
Up to 7.5 months (eight 28-day cycles)
title
International Myeloma Working Group (IMWG) Response Criteria
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice