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NCT01712789 · OUTCOME

Kaplan Meier Estimate of Duration of Response

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2022-01-10

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

What was measured

Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.

Analysis population: Includes participants with a response (sCR, VGPR or PR).

Groups in this outcome

Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)

Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)228

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)7.9Not reported6.488.78Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.48
        upper Limit
        8.78
        value
        7.9
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    units
    Participants
description
Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
    id
    OG000
    title
    Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
param Type
MEDIAN
population Description
Includes participants with a response (sCR, VGPR or PR).
reporting Status
POSTED
time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
title
Kaplan Meier Estimate of Duration of Response
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice