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NCT01078974 · OUTCOME

Maximum Tolerated Dose of Pomalidomide

Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia · Source last updated 2016-07-25

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
2 years

What was measured

To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.

Analysis population: The maximum tolerated dose was not determined due to study termination. Three participants experienced IgM flare causing them to be removed from the study early.

Groups in this outcome

Pomalidomide, Dexamethasone, Rituximab

Drug: pomalidomide Taken orally once a day Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 pomalidomide: Taken orally once a day dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

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, Dexamethasone, Rituximab7

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide, Dexamethasone, Rituximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.
groups
  1. description
    Drug: pomalidomide Taken orally once a day Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 pomalidomide: Taken orally once a day dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
    id
    OG000
    title
    Pomalidomide, Dexamethasone, Rituximab
param Type
NUMBER
population Description
The maximum tolerated dose was not determined due to study termination. Three participants experienced IgM flare causing them to be removed from the study early.
reporting Status
POSTED
time Frame
2 years
title
Maximum Tolerated Dose of Pomalidomide
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice