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NCT00478777 · OUTCOME

Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2011-11-03

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 827 days

What was measured

Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD). CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.

Analysis population: Full analysis set

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide Plus Dexamethasone144

Reported measurements

Complete response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone6Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone97Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone30Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone3Not reportedNot reportedNot reportedNot reported
Not evaluable (NE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone8Not reportedNot reportedNot reportedNot reported
CR + PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone103Not reportedNot reportedNot reportedNot reported
CR + PR + SD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone133Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        97
    title
    Partial response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Progressive disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Not evaluable (NE)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        103
    title
    CR + PR
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        133
    title
    CR + PR + SD
denoms
  1. counts
    1. group Id
      OG000
      value
      144
    units
    Participants
description
Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD). CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.
groups
  1. description
    Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
    id
    OG000
    title
    Lenalidomide Plus Dexamethasone
param Type
NUMBER
population Description
Full analysis set
reporting Status
POSTED
time Frame
Up to 827 days
title
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice