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NCT01159574 · OUTCOME

Overall Response Rate

Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma · Source last updated 2019-06-11

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
from baseline to cycle with maximum response, which was achieved on average after 2 cycles

What was measured

Best response rate was recorded for all patients, using the IMWG criteria.

Groups in this outcome

All Patients

ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle

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

Analysis denominator · Participants

GroupSource count
All Patients120

Reported measurements

Source class 1

stringent Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients6Not reportedNot reportedNot reportedNot reported

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients1Not reportedNot reportedNot reportedNot reported

Very Good Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients20Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients43Not reportedNot reportedNot reportedNot reported

Minimal Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients8Not reportedNot reportedNot reportedNot reported

stable disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients29Not reportedNot reportedNot reportedNot reported

Not evaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients3Not reportedNot reportedNot reportedNot reported

progression of disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      title
      stringent Complete Response
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Complete Response
    3. measurements
      1. group Id
        OG000
        value
        20
      title
      Very Good Partial Response
    4. measurements
      1. group Id
        OG000
        value
        43
      title
      Partial Response
    5. measurements
      1. group Id
        OG000
        value
        8
      title
      Minimal Response
    6. measurements
      1. group Id
        OG000
        value
        29
      title
      stable disease
    7. measurements
      1. group Id
        OG000
        value
        3
      title
      Not evaluable
    8. measurements
      1. group Id
        OG000
        value
        10
      title
      progression of disease
denoms
  1. counts
    1. group Id
      OG000
      value
      120
    units
    Participants
description
Best response rate was recorded for all patients, using the IMWG criteria.
groups
  1. description
    ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
    id
    OG000
    title
    All Patients
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
from baseline to cycle with maximum response, which was achieved on average after 2 cycles
title
Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice