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NCT01731886 · OUTCOME

Overall Survival Rate (OS)

Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma · Source last updated 2020-02-05

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
95% Confidence Interval
Time frame
4 years

What was measured

To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

Analysis population: Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

Groups in this outcome

Arm A: Low-dose Dexamethasone + Stem Cell Transplantation

Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).

Arm B: Low-dose Dexamethasone

Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.

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

Analysis denominator · Participants

GroupSource count
Arm A: Low-dose Dexamethasone + Stem Cell Transplantation25
Arm B: Low-dose Dexamethasone19

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Low-dose Dexamethasone + Stem Cell Transplantation79.8Not reported64.095.6Not reported
Arm B: Low-dose Dexamethasone78.9Not reported60.697.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.0
        upper Limit
        95.6
        value
        79.8
      2. group Id
        OG001
        lower Limit
        60.6
        upper Limit
        97.3
        value
        78.9
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      19
    units
    Participants
description
To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
    id
    OG000
    title
    Arm A: Low-dose Dexamethasone + Stem Cell Transplantation
  2. description
    Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
    id
    OG001
    title
    Arm B: Low-dose Dexamethasone
param Type
NUMBER
population Description
Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
reporting Status
POSTED
time Frame
4 years
title
Overall Survival Rate (OS)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice