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NCT00445484 · OUTCOME

6B Antibody Response to Prevnar Vaccine in Peripheral Blood

Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2015-08-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
fold change
Interval / dispersion
Standard Error
Time frame
basline and 8 weeks after second vaccination

What was measured

Serum IgG levels against the PVC serotype were measured by ELISA

Analysis population: Patients who showed evidence of disease progression while on study were not included in the analysis.

Groups in this outcome

Vaccine Started 14 Days Prior to Lenalidomide

Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally

Vaccine Started 45 Days After Lenalidomide

Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally

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

Analysis denominator · Participants

GroupSource count
Vaccine Started 14 Days Prior to Lenalidomide8
Vaccine Started 45 Days After Lenalidomide5

Reported measurements

Source class 1
Values in fold change · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Vaccine Started 14 Days Prior to Lenalidomide3.691.1Not reportedNot reportedNot reported
Vaccine Started 45 Days After Lenalidomide7.583.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1
        value
        3.69
      2. group Id
        OG001
        spread
        3.0
        value
        7.58
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Serum IgG levels against the PVC serotype were measured by ELISA
dispersion Type
Standard Error
groups
  1. description
    Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally
    id
    OG000
    title
    Vaccine Started 14 Days Prior to Lenalidomide
  2. description
    Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally
    id
    OG001
    title
    Vaccine Started 45 Days After Lenalidomide
param Type
MEAN
population Description
Patients who showed evidence of disease progression while on study were not included in the analysis.
reporting Status
POSTED
time Frame
basline and 8 weeks after second vaccination
title
6B Antibody Response to Prevnar Vaccine in Peripheral Blood
type
PRIMARY
unit Of Measure
fold change

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

Preserved source evidence · Not medical advice