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NCT00743288 · OUTCOME

Maximum Tolerated Dose (MTD)

Melphalan and Panobinostat (LBH589) for the Treatment of Patients With Recurrent Multiple Myeloma · Source last updated 2014-05-08

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

Measure
NUMBER
Unit
mg LBH589
Interval / dispersion
Not reported
Time frame
12 months

What was measured

Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study

Analysis population: MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.

Groups in this outcome

Melphalan and Panobinostat Schedule D3

20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1

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

Analysis denominator · Participants

GroupSource count
Melphalan and Panobinostat Schedule D36

Reported measurements

Source class 1
Values in mg LBH589 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melphalan and Panobinostat Schedule D320Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study
groups
  1. description
    20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
    id
    OG000
    title
    Melphalan and Panobinostat Schedule D3
param Type
NUMBER
population Description
MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.
reporting Status
POSTED
time Frame
12 months
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg LBH589

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

Preserved source evidence · Not medical advice