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NCT01057225 · OUTCOME

Maximum Tolerated Dose (Phase I)

Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma · Source last updated 2017-12-12

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From baseline to end of active treatment, up to 12 28-day cycles.

What was measured

To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs

Analysis population: All patients registered to a dose escalation Phase I group were analyzed for this endpoint.

Groups in this outcome

Phase I: Dose Level -1

Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.

Phase I: Dose Level 0

Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.

Phase I: Dose Level 1

Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.

Phase I: Dose Level 2

Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.

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

Analysis denominator · Participants

GroupSource count
Phase I: Dose Level -13
Phase I: Dose Level 03
Phase I: Dose Level 16
Phase I: Dose Level 27

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I: Dose Level -10Not reportedNot reportedNot reportedNot reported
Phase I: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase I: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I: Dose Level 23Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Dose Level
    param Value
    1
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Dose Level
    param Value
    1
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      7
    units
    Participants
description
To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs
groups
  1. description
    Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 15 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
    id
    OG000
    title
    Phase I: Dose Level -1
  2. description
    Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
    id
    OG001
    title
    Phase I: Dose Level 0
  3. description
    Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
    id
    OG002
    title
    Phase I: Dose Level 1
  4. description
    Patients receive: Oral 300 mg/m\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.
    id
    OG003
    title
    Phase I: Dose Level 2
param Type
NUMBER
population Description
All patients registered to a dose escalation Phase I group were analyzed for this endpoint.
reporting Status
POSTED
time Frame
From baseline to end of active treatment, up to 12 28-day cycles.
title
Maximum Tolerated Dose (Phase I)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice