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NCT00424047 · OUTCOME

Summary of Myeloma Response Rates Based on Best Response Assessment

A Study of 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
percentage of participants
Interval / dispersion
Not reported
Time frame
Randomization to 03 August 2005; up to 24 months

What was measured

Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.

Analysis population: Intent to Treat Population includes all participants who were randomized

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo Plus Dexamethasone

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

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 Dexamethasone176
Placebo Plus Dexamethasone175

Reported measurements

Complete Response (CR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone15.3Not reportedNot reportedNot reportedNot reported
Placebo Plus Dexamethasone4.0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone43.8Not reportedNot reportedNot reportedNot reported
Placebo Plus Dexamethasone19.4Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone29.0Not reportedNot reportedNot reportedNot reported
Placebo Plus Dexamethasone56.6Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone2.8Not reportedNot reportedNot reportedNot reported
Placebo Plus Dexamethasone14.3Not reportedNot reportedNot reportedNot reported
Not Evaluable (NE) those without response data
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone9.1Not reportedNot reportedNot reportedNot reported
Placebo Plus Dexamethasone5.7Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    statistical Comment
    Probability from Wilcoxon rank sum test
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    statistical Comment
    Probability from Wilcoxon rank sum test
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15.3
      2. group Id
        OG001
        value
        4.0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        43.8
      2. group Id
        OG001
        value
        19.4
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29.0
      2. group Id
        OG001
        value
        56.6
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2.8
      2. group Id
        OG001
        value
        14.3
    title
    Progressive Disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9.1
      2. group Id
        OG001
        value
        5.7
    title
    Not Evaluable (NE) those without response data
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    2. group Id
      OG001
      value
      175
    units
    Participants
description
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    OG000
    title
    Lenalidomide Plus Dexamethasone
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
    id
    OG001
    title
    Placebo Plus Dexamethasone
param Type
NUMBER
population Description
Intent to Treat Population includes all participants who were randomized
reporting Status
POSTED
time Frame
Randomization to 03 August 2005; up to 24 months
title
Summary of Myeloma Response Rates Based on Best Response Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice