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NCT01432600 · OUTCOME

Phase II - Median Progression Free Survival (PFS)

Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide · Source last updated 2017-05-23

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
36 Months

What was measured

Progression free survival per treatment arm. Progressive Disease (PD) requires one of the following, increase of greater than or equal to 25% from baseline in: Serum M-component; Urine M-component; The difference between involved and uninvolved sFLC levels; The size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia.

Analysis population: All Phase II Participants.

Groups in this outcome

B: Pomalidomide and Dexamethasone

Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.

C: Pomalidomide, Dexamethasone, Cyclophosphamide

Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.

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

Analysis denominator · Participants

GroupSource count
B: Pomalidomide and Dexamethasone36
C: Pomalidomide, Dexamethasone, Cyclophosphamide34

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
B: Pomalidomide and Dexamethasone4.4Not reported2.35.7Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide9.5Not reported4.614Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        5.7
        value
        4.4
      2. group Id
        OG001
        lower Limit
        4.6
        upper Limit
        14
        value
        9.5
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      34
    units
    Participants
description
Progression free survival per treatment arm. Progressive Disease (PD) requires one of the following, increase of greater than or equal to 25% from baseline in: Serum M-component; Urine M-component; The difference between involved and uninvolved sFLC levels; The size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia.
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.
    id
    OG000
    title
    B: Pomalidomide and Dexamethasone
  2. description
    Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
    id
    OG001
    title
    C: Pomalidomide, Dexamethasone, Cyclophosphamide
param Type
MEDIAN
population Description
All Phase II Participants.
reporting Status
POSTED
time Frame
36 Months
title
Phase II - Median Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice