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NCT01997840 · OUTCOME

Progression-free Survival (PFS)

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
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).

What was measured

Progression-free survival (PFS) was defined as the time from first dose of study treatment to the first documentation of progressive disease (PD) or death from any cause during study PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. * New bone lesions or soft tissue plasmacytomas or increase size of existing bone lesions or soft tissue plasmacytomas. * Hypercalcemia attributed to myeloma. Calculated using Kaplan-Meier estimates.

Analysis population: All treated participants in the Efficacy Evaluable 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 177
Phase 2 - ACY-1215 Dose Level 37

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b - ACY-1215 Dose Level 110.30Not reported8.1048.90Not reported
Phase 1b - ACY-1215 Dose Level 36.30Not reported4.358.05Not reported
Phase 2 - ACY-1215 Dose Level 120.00Not reported9.1041.60Not reported
Phase 2 - ACY-1215 Dose Level 362.70Not reported19.9099.90Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.10
        upper Limit
        48.90
        value
        10.30
      2. group Id
        OG001
        lower Limit
        4.35
        upper Limit
        8.05
        value
        6.30
      3. group Id
        OG002
        lower Limit
        9.10
        upper Limit
        41.60
        value
        20.00
      4. group Id
        OG003
        lower Limit
        19.90
        upper Limit
        99.90
        value
        62.70
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      77
    4. group Id
      OG003
      value
      7
    units
    Participants
description
Progression-free survival (PFS) was defined as the time from first dose of study treatment to the first documentation of progressive disease (PD) or death from any cause during study PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. * New bone lesions or soft tissue plasmacytomas or increase size of existing bone lesions or soft tissue plasmacytomas. * Hypercalcemia attributed to myeloma. Calculated using Kaplan-Meier estimates.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
All treated participants in the Efficacy Evaluable population.
reporting Status
POSTED
time Frame
From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Weeks

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Preserved source evidence · Not medical advice