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NCT00148317 · OUTCOME

Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)

Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma · Source last updated 2017-07-18

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
Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization

What was measured

Myeloma response criteria developed by Bladé et al. was used to categorize response.

Analysis population: All 38 patients were treated with DoVeD consolidation therapy (Vel + DEX with or without DOXIL). Of the 38 patients enrolled, 27 proceeded to mobilization (11 did not undergo mobilization). Responses were assessed prior to mobilization (post DoVED), and again after mobilization, to see if mobilization improved patient response.

Groups in this outcome

Treatment Arm - Post Mobilization

This is the response rate assessed for patients after their bortezomib-based mobilization.

Treatment Arm - Responses Prior to Mobilization

This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).

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

Analysis denominator · Participants

GroupSource count
Treatment Arm - Post Mobilization27
Treatment Arm - Responses Prior to Mobilization38

Reported measurements

Stringent Complete Response (sCR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm - Post Mobilization4Not reportedNot reportedNot reportedNot reported
Treatment Arm - Responses Prior to Mobilization0Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm - Post Mobilization3Not reportedNot reportedNot reportedNot reported
Treatment Arm - Responses Prior to Mobilization1Not reportedNot reportedNot reportedNot reported
Very Good Partial response (VGPR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm - Post Mobilization6Not reportedNot reportedNot reportedNot reported
Treatment Arm - Responses Prior to Mobilization1Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm - Post Mobilization13Not reportedNot reportedNot reportedNot reported
Treatment Arm - Responses Prior to Mobilization2Not reportedNot reportedNot reportedNot reported
Other Response (progression, stable disease, etc)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm - Post Mobilization1Not reportedNot reportedNot reportedNot reported
Treatment Arm - Responses Prior to Mobilization6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    Stringent Complete Response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
    title
    Very Good Partial response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        2
    title
    Partial Response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
    title
    Other Response (progression, stable disease, etc)
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Myeloma response criteria developed by Bladé et al. was used to categorize response.
groups
  1. description
    This is the response rate assessed for patients after their bortezomib-based mobilization.
    id
    OG000
    title
    Treatment Arm - Post Mobilization
  2. description
    This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
    id
    OG001
    title
    Treatment Arm - Responses Prior to Mobilization
param Type
NUMBER
population Description
All 38 patients were treated with DoVeD consolidation therapy (Vel + DEX with or without DOXIL). Of the 38 patients enrolled, 27 proceeded to mobilization (11 did not undergo mobilization). Responses were assessed prior to mobilization (post DoVED), and again after mobilization, to see if mobilization improved patient response.
reporting Status
POSTED
time Frame
Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization
title
Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice