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NCT01351623 · OUTCOME

To Evaluate the Best Overall Response Rate (ORR)

Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2017-04-13

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions

Analysis population: Participants who completed 4 cycles of treatment or whose disease progressed prior to completion of 4 cycles.

Groups in this outcome

Carfilzomib

A single arm, open-label, single institution phase 2 clinical trial is planned. Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib35

Reported measurements

Source class 1

Complete Response/CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib1Not reportedNot reportedNot reportedNot reported

Very Good Partial Response/PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib8Not reportedNot reportedNot reportedNot reported

Partial Response/PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib9Not reportedNot reportedNot reportedNot reported

Minimal Response/MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib3Not reportedNot reportedNot reportedNot reported

Stable Disease/SD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib2Not reportedNot reportedNot reportedNot reported

Progressin of Disease/POD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Complete Response/CR
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      Very Good Partial Response/PR
    3. measurements
      1. group Id
        OG000
        value
        9
      title
      Partial Response/PR
    4. measurements
      1. group Id
        OG000
        value
        3
      title
      Minimal Response/MR
    5. measurements
      1. group Id
        OG000
        value
        2
      title
      Stable Disease/SD
    6. measurements
      1. group Id
        OG000
        value
        12
      title
      Progressin of Disease/POD
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
groups
  1. description
    A single arm, open-label, single institution phase 2 clinical trial is planned. Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
    id
    OG000
    title
    Carfilzomib
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who completed 4 cycles of treatment or whose disease progressed prior to completion of 4 cycles.
reporting Status
POSTED
time Frame
2 years
title
To Evaluate the Best Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice