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NCT00461045 · OUTCOME

Number of Patients Exhibiting a Given Overall Response as Determined by Investigator

Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-12-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Through study completion, an average of 6.09 weeks.

What was measured

Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.

Groups in this outcome

MRZ 0.5 mg/m^2

Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles

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

Analysis denominator · Participants

GroupSource count
MRZ 0.5 mg/m^215

Reported measurements

Stringent Complete Response (sCR) or better
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^20Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^20Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^20Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^20Not reportedNot reportedNot reportedNot reported
Minimal Response (MR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^20Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^24Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^29Not reportedNot reportedNot reportedNot reported
Not Evaluated
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Stringent Complete Response (sCR) or better
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Very Good Partial Response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Minimal Response (MR)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Stable Disease (SD)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Progressive Disease (PD)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Not Evaluated
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.
groups
  1. description
    Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    id
    OG000
    title
    MRZ 0.5 mg/m^2
param Type
NUMBER
reporting Status
POSTED
time Frame
Through study completion, an average of 6.09 weeks.
title
Number of Patients Exhibiting a Given Overall Response as Determined by Investigator
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice