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NCT01946152 · OUTCOME

Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)

Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2021-07-30

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
After 112 days (4 courses) of therapy

What was measured

Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC): Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \<100 mg/24 hours; Partial Response (PR), \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h; Stable Disease (SD) = CR + PR.

Groups in this outcome

Cohort 0

4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.

Cohort I

5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.

Cohort II

6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.

Maximum Tolerated Dose (MTD)

5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.

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 03
Cohort I3
Cohort II6
Maximum Tolerated Dose (MTD)8

Reported measurements

Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 01Not reportedNot reportedNot reportedNot reported
Cohort I2Not reportedNot reportedNot reportedNot reported
Cohort II3Not reportedNot reportedNot reportedNot reported
Maximum Tolerated Dose (MTD)6Not reportedNot reportedNot reportedNot reported
Progression Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 00Not reportedNot reportedNot reportedNot reported
Cohort I1Not reportedNot reportedNot reportedNot reported
Cohort II1Not reportedNot reportedNot reportedNot reported
Maximum Tolerated Dose (MTD)0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 01Not reportedNot reportedNot reportedNot reported
Cohort I0Not reportedNot reportedNot reportedNot reported
Cohort II1Not reportedNot reportedNot reportedNot reported
Maximum Tolerated Dose (MTD)1Not reportedNot reportedNot reportedNot reported
Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 00Not reportedNot reportedNot reportedNot reported
Cohort I0Not reportedNot reportedNot reportedNot reported
Cohort II0Not reportedNot reportedNot reportedNot reported
Maximum Tolerated Dose (MTD)0Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 01Not reportedNot reportedNot reportedNot reported
Cohort I0Not reportedNot reportedNot reportedNot reported
Cohort II0Not reportedNot reportedNot reportedNot reported
Maximum Tolerated Dose (MTD)1Not reportedNot reportedNot reportedNot reported
Non evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 00Not reportedNot reportedNot reportedNot reported
Cohort I0Not reportedNot reportedNot reportedNot reported
Cohort II1Not reportedNot reportedNot reportedNot reported
Maximum Tolerated Dose (MTD)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        6
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Progression Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Complete Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    Very Good Partial Response (VGPR)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Non evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC): Complete Response (CR), Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \<100 mg/24 hours; Partial Response (PR), \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h; Stable Disease (SD) = CR + PR.
groups
  1. description
    4 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
    id
    OG000
    title
    Cohort 0
  2. description
    5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
    id
    OG001
    title
    Cohort I
  3. description
    6 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
    id
    OG002
    title
    Cohort II
  4. description
    5 mg of Pomalidomide Daily days 1 - 21. 40 mg Dexamethasone On days 1, 8. 15, 22. 4mcg/kg of Zarxio (G-CSF) Days 22- 28.
    id
    OG003
    title
    Maximum Tolerated Dose (MTD)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
After 112 days (4 courses) of therapy
title
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice