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NCT01997840 · OUTCOME

Plasma Levels of ACY-1215 and Pomalidomide - 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8

Analysis population: All treated participants with available PK results. Prespecified to be reported for Phase 1b only. Data not collected.

Groups in this outcome

Phase 1b - ACY-1215 Dose Level 1

Participants received 160 mg ACY-1215 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.

Phase 1b - ACY-1215 Dose Level 3

Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once 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-1215 Dose Level 10
Phase 1b - ACY-1215 Dose Level 30

Reported measurements

ACY-1215
Pomalidomide
Complete source fields
classes
  1. title
    ACY-1215
  2. title
    Pomalidomide
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
groups
  1. description
    Participants received 160 mg ACY-1215 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 Dose Level 1
  2. description
    Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once 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
    OG001
    title
    Phase 1b - ACY-1215 Dose Level 3
population Description
All treated participants with available PK results. Prespecified to be reported for Phase 1b only. Data not collected.
reporting Status
POSTED
time Frame
Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8
title
Plasma Levels of ACY-1215 and Pomalidomide - Phase 1b
type
SECONDARY

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

Preserved source evidence · Not medical advice