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NCT01979276 · OUTCOME

Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone

Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma · Source last updated 2018-06-06

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
During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)

What was measured

Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)

Analysis population: MTD not established as study terminated while only 2 subjects enrolled. Only romidepsin dose tested was 9mg/mg2

Groups in this outcome

ALL Patients

Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined

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

Analysis denominator · Participants

GroupSource count
ALL Patients0

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
Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)
groups
  1. description
    Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
    id
    OG000
    title
    ALL Patients
population Description
MTD not established as study terminated while only 2 subjects enrolled. Only romidepsin dose tested was 9mg/mg2
reporting Status
POSTED
time Frame
During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)
title
Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone
type
PRIMARY

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

Preserved source evidence · Not medical advice