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NCT01852799 · OUTCOME

Evaluation of Responses(PFS)

A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma · Source last updated 2018-08-10

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of signing informed consent form until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

What was measured

Efficacy parameters PFS will be evaluated by normal methodology. PFS =（date of signing informed consent form minus the date of first documented progression or date of death from any cause plus 1）/30.5（months）

Groups in this outcome

PAD Followed by ASCT

Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone. After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle) Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle) Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.

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

Analysis denominator · Participants

GroupSource count
PAD Followed by ASCT18

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT13.7Not reported10.313.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.3
        upper Limit
        13.7
        value
        13.7
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Efficacy parameters PFS will be evaluated by normal methodology. PFS =（date of signing informed consent form minus the date of first documented progression or date of death from any cause plus 1）/30.5（months）
dispersion Type
95% Confidence Interval
groups
  1. description
    Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone. After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle) Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle) Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
    id
    OG000
    title
    PAD Followed by ASCT
param Type
MEDIAN
reporting Status
POSTED
time Frame
From date of signing informed consent form until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
title
Evaluation of Responses(PFS)
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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

Preserved source evidence · Not medical advice