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NCT01997840 · OUTCOME

Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b

ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma · Source last updated 2025-03-04

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

Measure
NUMBER
Unit
mg/day
Interval / dispersion
Not reported
Time frame
From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).

What was measured

The maximum tolerated dose (MTD) was defined as the highest dose level at which no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) within the first 28-day cycle. If no more than 1 of these 6 patients experienced a DLT within the first 28-day cycle, then the last dose level enrolled to meet these criteria was identified as the recommended dose for the Phase 2 segment of the study.

Analysis population: All treated participants in Phase 1b. Prespecified to be reported as combined for Phase 1b only.

Groups in this outcome

Phase 1b - ACY-1215

Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 1b - ACY-12157

Reported measurements

Source class 1
Values in mg/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b - ACY-1215320Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        320
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
The maximum tolerated dose (MTD) was defined as the highest dose level at which no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) within the first 28-day cycle. If no more than 1 of these 6 patients experienced a DLT within the first 28-day cycle, then the last dose level enrolled to meet these criteria was identified as the recommended dose for the Phase 2 segment of the study.
groups
  1. description
    Participants received either 160 mg ACY-1215 once per day (Dose Level 1) or 160 mg ACY-1215 twice per day (Dose Level 3) and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
    id
    OG000
    title
    Phase 1b - ACY-1215
param Type
NUMBER
population Description
All treated participants in Phase 1b. Prespecified to be reported as combined for Phase 1b only.
reporting Status
POSTED
time Frame
From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).
title
Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b
type
PRIMARY
unit Of Measure
mg/day

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

Preserved source evidence · Not medical advice