Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01057225 · OUTCOME

Complete Response (Phase II)

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
Following the first 4 courses of treatment

What was measured

In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.

Groups in this outcome

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.

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.

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.

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
Dose Level -13
Dose Level 025
Dose Level 129
Dose Level 27

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level -10Not reportedNot reportedNot reportedNot reported
Dose Level 02Not reportedNot reportedNot reportedNot reported
Dose Level 13Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      29
    4. group Id
      OG003
      value
      7
    units
    Participants
description
In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.
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
    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
    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
    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
    Dose Level 2
param Type
NUMBER
reporting Status
POSTED
time Frame
Following the first 4 courses of treatment
title
Complete Response (Phase II)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice