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NCT00445692 · OUTCOME

Time to Disease Progression

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma · Source last updated 2019-11-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Up to 10.25 years

What was measured

International Myeloma Working Group Uniform Response Criteria was used

Analysis population: Measured among the 20 patients who progressed

Groups in this outcome

Treatment (Clarithromycin, Dexamethasone, Lenalidomide)

Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given PO Dexamethasone: Given PO Lenalidomide: Given PO

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

Analysis denominator · Participants

GroupSource count
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)20

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)30.5Not reported1568.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15
        upper Limit
        68.4
        value
        30.5
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
International Myeloma Working Group Uniform Response Criteria was used
dispersion Type
Full Range
groups
  1. description
    Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given PO Dexamethasone: Given PO Lenalidomide: Given PO
    id
    OG000
    title
    Treatment (Clarithromycin, Dexamethasone, Lenalidomide)
param Type
MEDIAN
population Description
Measured among the 20 patients who progressed
reporting Status
POSTED
time Frame
Up to 10.25 years
title
Time to Disease Progression
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice