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NCT00378105 · OUTCOME

Objective Response Rate of the Drug Combination in This Patient Populations.

Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2026-02-24

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
90% Confidence Interval
Time frame
Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant.

What was measured

Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.

Analysis population: The numbers excluded 2 patients who went off study prior to start of therapy

Groups in this outcome

Phase 1 Population

Not reported

Phase II Population

Not reported

Total

Not reported

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

Analysis denominator · Participants

GroupSource count
Phase 1 Population31
Phase II Population35
Total66

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1 Population100Not reported91100Not reported
Phase II Population100Not reported92100Not reported
Total100Not reported96100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        92
        upper Limit
        100
        value
        100
      3. group Id
        OG002
        lower Limit
        96
        upper Limit
        100
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      35
    3. group Id
      OG002
      value
      66
    units
    Participants
description
Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.
dispersion Type
90% Confidence Interval
groups
  1. id
    OG000
    title
    Phase 1 Population
  2. id
    OG001
    title
    Phase II Population
  3. id
    OG002
    title
    Total
param Type
NUMBER
population Description
The numbers excluded 2 patients who went off study prior to start of therapy
reporting Status
POSTED
time Frame
Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant.
title
Objective Response Rate of the Drug Combination in This Patient Populations.
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice