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NCT00056160 · OUTCOME

Myeloma Response

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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 Unblinding (07 Jun 2005)

What was measured

The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.

Analysis population: Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.

Groups in this outcome

CC-5013/Dex

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

Placebo/Dex

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

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

Analysis denominator · Participants

GroupSource count
CC-5013/Dex177
Placebo/Dex176

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CC-5013/Dex107Not reportedNot reportedNot reportedNot reported
Placebo/Dex34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        34
denoms
  1. counts
    1. group Id
      OG000
      value
      177
    2. group Id
      OG001
      value
      176
    units
    Participants
description
The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
groups
  1. description
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    id
    OG000
    title
    CC-5013/Dex
  2. description
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    id
    OG001
    title
    Placebo/Dex
param Type
NUMBER
population Description
Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.
reporting Status
POSTED
time Frame
Up to Unblinding (07 Jun 2005)
title
Myeloma Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice