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NCT00925782 · OUTCOME

Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT

PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation · Source last updated 2019-12-17

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

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
30 days

What was measured

Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed. Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered.

Analysis population: The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.

Groups in this outcome

Open-label, Randomized, Crossover Study

Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.

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

Analysis denominator · Participants

GroupSource count
Open-label, Randomized, Crossover Study24

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Open-label, Randomized, Crossover Study111Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed. Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered.
dispersion Type
Standard Deviation
groups
  1. description
    Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.
    id
    OG000
    title
    Open-label, Randomized, Crossover Study
param Type
MEAN
population Description
The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.
reporting Status
POSTED
time Frame
30 days
title
Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice