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NCT01083602 · OUTCOME

Responders to Treatment

Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma · Source last updated 2017-12-21

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
after eight cycyles of treatment (24 weeks)

What was measured

The primary endpoint for this phase II study of patients with bortezomib-refractory MM is response after a maximum of 8 cycles of therapy as defined by the modified EBMT criteria.

Analysis population: Full Analysis Set

Groups in this outcome

Panobinostat + Bortezomib & Dexamethasone

panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma

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

Analysis denominator · Participants

GroupSource count
Panobinostat + Bortezomib & Dexamethasone55

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone0Not reported22.246.7Not reported
near Complete Response(nCR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone1Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone18Not reportedNot reportedNot reportedNot reported
Minimal Response (MR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone10Not reportedNot reportedNot reportedNot reported
No Change
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone20Not reportedNot reportedNot reportedNot reported
Pregressive Disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone3Not reportedNot reportedNot reportedNot reported
Unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib & Dexamethasone3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.2
        upper Limit
        46.7
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    near Complete Response(nCR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Minimal Response (MR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    No Change
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Pregressive Disease (PD)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
The primary endpoint for this phase II study of patients with bortezomib-refractory MM is response after a maximum of 8 cycles of therapy as defined by the modified EBMT criteria.
groups
  1. description
    panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
    id
    OG000
    title
    Panobinostat + Bortezomib & Dexamethasone
param Type
NUMBER
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
after eight cycyles of treatment (24 weeks)
title
Responders to Treatment
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice