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NCT01946152 · OUTCOME

Maximum Tolerated Dose (MTD) (Phase I)

Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2021-07-30

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
28 days

What was measured

Safety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)

Groups in this outcome

Maximum Tolerated Dose (MTD)

5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.

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

Analysis denominator · Participants

GroupSource count
Maximum Tolerated Dose (MTD)8

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Maximum Tolerated Dose (MTD)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Safety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I)
groups
  1. description
    5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
    id
    OG000
    title
    Maximum Tolerated Dose (MTD)
param Type
NUMBER
reporting Status
POSTED
time Frame
28 days
title
Maximum Tolerated Dose (MTD) (Phase I)
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice