NCT01023308 · OUTCOME

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma · Source last updated 2020-03-17

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

Measure: NUMBER
Unit: % participants with response
Interval / dispersion: Not reported
Time frame: 45 months

What was measured

Best overall response based on mEBMT criteria per investigator assessment

Groups in this outcome

Panobinostat + Bortezomib

Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.

Placebo + Bortezomib

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

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

Analysis denominator · Participants

Group	Source count
Panobinostat + Bortezomib	387
Placebo + Bortezomib	381

Reported measurements

Source class 1

Values in % participants with response · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Panobinostat + Bortezomib	60.7	Not reported	Not reported	Not reported	Not reported
Placebo + Bortezomib	54.6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
60.7
group Id
OG001
value
54.6

denoms

counts
group Id
OG000
value
387
group Id
OG001
value
381
units
Participants

description

Best overall response based on mEBMT criteria per investigator assessment

groups

description
Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
id
OG000
title
Panobinostat + Bortezomib
description
Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
id
OG001
title
Placebo + Bortezomib

param Type

NUMBER

reporting Status

POSTED

time Frame

45 months

title

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

type

SECONDARY

unit Of Measure

% participants with response

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Preserved source evidence · Not medical advice