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NCT02722941 · OUTCOME

Complete Response Rate

Panobinostat (LBH589): Multiple Myeloma - Autologous Hematopoietic Cell Transplantation (HCT) · Source last updated 2022-11-01

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

Measure
NUMBER
Unit
percentage
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

Complete Response (CR) rate to panobinostat maintenance therapy after autologous HCT. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow.

Groups in this outcome

Cohort A: Maintenance Therapy

Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.

Cohort B: Maintenance Therapy

Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.

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 A: Maintenance Therapy15
Cohort B: Maintenance Therapy15

Reported measurements

Source class 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A: Maintenance Therapy73.33Not reported44.992.2Not reported
Cohort B: Maintenance Therapy66.6Not reported38.488.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.9
        upper Limit
        92.2
        value
        73.33
      2. group Id
        OG001
        lower Limit
        38.4
        upper Limit
        88.2
        value
        66.6
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Complete Response (CR) rate to panobinostat maintenance therapy after autologous HCT. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow.
dispersion Type
95% Confidence Interval
groups
  1. description
    Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.
    id
    OG000
    title
    Cohort A: Maintenance Therapy
  2. description
    Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.
    id
    OG001
    title
    Cohort B: Maintenance Therapy
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 5 years
title
Complete Response Rate
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice