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NCT00581919 · OUTCOME

Progression-free Survival

Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma · Source last updated 2019-12-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.

What was measured

Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.

Groups in this outcome

Bort, Dex, and Dox With ALCAR

Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long

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

Analysis denominator · Participants

GroupSource count
Bort, Dex, and Dox With ALCAR32

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bort, Dex, and Dox With ALCAR5Not reported1.037.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        37.0
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.
dispersion Type
Full Range
groups
  1. description
    Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
    id
    OG000
    title
    Bort, Dex, and Dox With ALCAR
param Type
MEDIAN
reporting Status
POSTED
time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice