Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03440411 · OUTCOME

Quality of Life With QLQ-MY(Myeloma)24

Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment · Source last updated 2021-03-10

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
57 months

What was measured

outcome will be measured with QLQ-MY24 at baseline, every 2 months during the first year, and then every 6 months for the comparison B vs B and I vs II.

Analysis population: data could not be reported in the data table since analysis was not performed according to the lower sample size and QLQ missing

Groups in this outcome

ARM A-I

Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

ARM A-II

Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

ARM B-I

Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

ARM B-II

Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

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-I0
ARM A-II0
ARM B-I0
ARM B-II0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
outcome will be measured with QLQ-MY24 at baseline, every 2 months during the first year, and then every 6 months for the comparison B vs B and I vs II.
groups
  1. description
    Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    OG000
    title
    ARM A-I
  2. description
    Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    OG001
    title
    ARM A-II
  3. description
    Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    OG002
    title
    ARM B-I
  4. description
    Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    OG003
    title
    ARM B-II
population Description
data could not be reported in the data table since analysis was not performed according to the lower sample size and QLQ missing
reporting Status
POSTED
time Frame
57 months
title
Quality of Life With QLQ-MY(Myeloma)24
type
SECONDARY

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

Preserved source evidence · Not medical advice