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NCT00985907 · OUTCOME

Maximum Tolerated Dose (MTD) (Phase 1)

Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma · Source last updated 2020-06-17

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

The MTD will be considered the dose below where \<= 3 patients experience a DLT and the dose that two cycles can be given without meeting toxicity criteria.

Analysis population: Data not collected

Groups in this outcome

Doxil® + Melphalan + Velcade (DMV)

Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d Melphalan: IV over 30 min, Day 1 q28d Velcade®: IV bolus, Day 1, 4, 8, 11 q28d Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2 Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2

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

Analysis denominator · Participants

GroupSource count
Doxil® + Melphalan + Velcade (DMV)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The MTD will be considered the dose below where \<= 3 patients experience a DLT and the dose that two cycles can be given without meeting toxicity criteria.
groups
  1. description
    Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d Melphalan: IV over 30 min, Day 1 q28d Velcade®: IV bolus, Day 1, 4, 8, 11 q28d Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2 Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
    id
    OG000
    title
    Doxil® + Melphalan + Velcade (DMV)
population Description
Data not collected
reporting Status
POSTED
time Frame
Up to 1 year
title
Maximum Tolerated Dose (MTD) (Phase 1)
type
PRIMARY

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

Preserved source evidence · Not medical advice