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NCT01658904 · OUTCOME

Engraftment Failure Transplant Related Mortality

Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma · Source last updated 2016-06-01

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
up to day 100

What was measured

Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.

Groups in this outcome

Cohort 1- CFZ 20 mg/m^2 (Day 1,2)

Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.

Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)

Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.

Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)

Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.

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

Analysis denominator · Participants

GroupSource count
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)1
Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)0
Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)0

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.
groups
  1. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    OG000
    title
    Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
  2. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    OG001
    title
    Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
  3. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    OG002
    title
    Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
param Type
NUMBER
reporting Status
POSTED
time Frame
up to day 100
title
Engraftment Failure Transplant Related Mortality
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice