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NCT01852799 · OUTCOME

Evaluation of Responses

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up

What was measured

Evaluation of responses was performed every cycle. Responses were assessed according to the european group for blood and marrow transplantation（EBMT） criteria (An attempt will be made to collect data for the assessment of stringent complete response (sCR) if these data are available.). Other efficacy parameters including PFS and 1-year overall survival rate and overall survival will be evaluated by normal methodology. According to EBMT criteria, responses were assessed by changes in the level of the serum paraprotein and/or urinary light chain excretion.The specific assessment rules may refer to EBMT criteria for MM.

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

After 4-month PAD treatment

sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT4Not reportedNot reportedNot reportedNot reported

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT0Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT12Not reportedNot reportedNot reportedNot reported

MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

NC

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT0Not reportedNot reportedNot reportedNot reported
After ASCT

sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT4Not reportedNot reportedNot reportedNot reported

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT0Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT12Not reportedNot reportedNot reportedNot reported

MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

NC

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT0Not reportedNot reportedNot reportedNot reported
End of study

sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT2Not reportedNot reportedNot reportedNot reported

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT9Not reportedNot reportedNot reportedNot reported

MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

NC

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT1Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      sCR
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      CR
    3. measurements
      1. group Id
        OG000
        value
        12
      title
      PR
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      MR
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      NC
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      PD
    title
    After 4-month PAD treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      sCR
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      CR
    3. measurements
      1. group Id
        OG000
        value
        12
      title
      PR
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      MR
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      NC
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      PD
    title
    After ASCT
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      sCR
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      CR
    3. measurements
      1. group Id
        OG000
        value
        9
      title
      PR
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      MR
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      NC
    6. measurements
      1. group Id
        OG000
        value
        4
      title
      PD
    title
    End of study
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Evaluation of responses was performed every cycle. Responses were assessed according to the european group for blood and marrow transplantation（EBMT） criteria (An attempt will be made to collect data for the assessment of stringent complete response (sCR) if these data are available.). Other efficacy parameters including PFS and 1-year overall survival rate and overall survival will be evaluated by normal methodology. According to EBMT criteria, responses were assessed by changes in the level of the serum paraprotein and/or urinary light chain excretion.The specific assessment rules may refer to EBMT criteria for MM.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up
title
Evaluation of Responses
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice