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NCT01432600 · OUTCOME

Phase I - Maximum Tolerated Dose (MTD)

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
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
28 Days

What was measured

The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days.

Analysis population: All Phase I Participants.

Groups in this outcome

A: Dose Escalation of Cyclophosphamide

Phase I: 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
A: Dose Escalation of Cyclophosphamide10

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Dose Escalation of Cyclophosphamide400Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        400
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days.
groups
  1. description
    Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
    id
    OG000
    title
    A: Dose Escalation of Cyclophosphamide
param Type
NUMBER
population Description
All Phase I Participants.
reporting Status
POSTED
time Frame
28 Days
title
Phase I - Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice