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NCT01997840 · OUTCOME

Number of Participants With Adverse Events (AEs) Leading to Discontinuation

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks)

What was measured

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

Analysis population: All treated participants in the Safety population.

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.

Phase 2 - 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 2 - 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 13
Phase 1b - ACY-1215 Dose Level 34
Phase 2 - ACY-1215 Dose Level 185
Phase 2 - ACY-1215 Dose Level 311

Reported measurements

ACY-1215
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b - ACY-1215 Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1b - ACY-1215 Dose Level 30Not reportedNot reportedNot reportedNot reported
Phase 2 - ACY-1215 Dose Level 113Not reportedNot reportedNot reportedNot reported
Phase 2 - ACY-1215 Dose Level 31Not reportedNot reportedNot reportedNot reported
Pomalidomide
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b - ACY-1215 Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1b - ACY-1215 Dose Level 30Not reportedNot reportedNot reportedNot reported
Phase 2 - ACY-1215 Dose Level 113Not reportedNot reportedNot reportedNot reported
Phase 2 - ACY-1215 Dose Level 31Not reportedNot reportedNot reportedNot reported
Dexamethasone
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b - ACY-1215 Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1b - ACY-1215 Dose Level 30Not reportedNot reportedNot reportedNot reported
Phase 2 - ACY-1215 Dose Level 116Not reportedNot reportedNot reportedNot reported
Phase 2 - ACY-1215 Dose Level 31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        1
    title
    ACY-1215
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        1
    title
    Pomalidomide
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        1
    title
    Dexamethasone
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      85
    4. group Id
      OG003
      value
      11
    units
    Participants
description
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
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
  3. 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
    OG002
    title
    Phase 2 - ACY-1215 Dose Level 1
  4. 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
    OG003
    title
    Phase 2 - ACY-1215 Dose Level 3
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants in the Safety population.
reporting Status
POSTED
time Frame
From first dose until 30 days after last dose of study drug (assessed for an average of approximately 55 weeks to a maximum of approximately 456 weeks)
title
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice