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TerminatedNCT01997840Updated Mar 4, 2025Results posted

ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma

A Phase 1/2 interventional study of ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone in Multiple Myeloma, sponsored by Celgene. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Celgene · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Change in business priorities.
Phase
Phase 1/2
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma.

Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasms by Histologic Type
  • Neoplasms
  • Blood Protein Disorders
  • Hematologic Diseases
  • Dexamethasone
  • Dexamethasone acetate
  • Pomalidomide
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 103 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must have a documented diagnosis of multiple myeloma and have relapsed-and-refractory disease. Patients must have received at least 2 lines of prior therapies. Patients must have relapsed after having achieved at least stable disease (SD) for at least one cycle of treatment to at least one prior regimen and then developed progressive disease (PD). Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease)
  • Must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
  • Must not be a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT
  • Must have measurable levels of myeloma paraprotein in serum (≥ 0.5 g/dL) or urine (≥ 0.2 g/24 hours)
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to, and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods,and Education and Counseling Guidance must be followed per protocol
  • Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating females
  • Prior therapy with HDAC inhibitor

  • Any of the following laboratory abnormalities:

    • ANC \< 1,000/µL
    • Platelet count \< 75,000/ µL for patients in whom \< 50% of bone marrow nucleated cells are plasma cells; and \< 50,000/ µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
    • Hemoglobin \< 8g/dL (\<4.9 mmol/L; prior red blood cell [RBC] transfusion is permitted)
    • Creatine clearance \< 45mL/min according to Cockcroft-Gault formula. If creatine clearance calculated from the 24-hour urine sample is ≥ 45 mL/min, patient will qualify for the study
    • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), or serum glutamic pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT) > 3.0 × ULN
    • Serum total bilirubin > 2.0 mg/dL

  • Prior history of malignancies, other than MM, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:

    • Basal or squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix or breast
    • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
  • Corrected QT interval using Fridericia's formula (QTcF) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG)
  • Positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
  • Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (such as Steven Johnson Syndrome). Hypersensitivity, such as rash, that can be medically managed is allowable
  • Peripheral neuropathy ≥ Grade 2 despite supportive therapy
  • Radiotherapy or systemic therapy (standard or an investigational or biologic anticancer agent) within 14 days of initiation of study drug treatment
  • Current enrollment in another clinical trial involving treatment and/or is receiving an investigational agent for any reason
  • Inability or unwillingness to comply with birth control requirements or regional REMS/RevAid programs
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    ACY-1215 in combination with pomalidomide and dexamethasone

    ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone

    Drug: ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone

Interventions

  • DrugACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone

    ACY-1215 (Ricolinostat) 160mg QD Days 1-21 with pomalidomide 4mg QD Days 1-21 and dexamethasone 40mg QD Days 1,8,15,22 of a 28-day cycle

    Also known as: Pomalyst, Ricolinostat, Dexamethasone

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).

  2. Overall Response Rate (ORR) Per Investigator - Phase 2

    Overall response rate (ORR) is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.

    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).

Secondary outcomes

  1. Time to Response (TTR)

    Time to response (TTR) was defined as the time from first dose of study treatment to the first documentation of response (either partial response (PR) or complete response (CR)). CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.

    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).

  2. Duration of Response (DoR)

    Duration of Response (DOR) was defined as the time from first partial response (PR) or complete response (CR) to the first documentation of progressive disease (PD) or death. PR: * \>= 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by \>= 90% or to less than 200 mg per 24 hours. * For non-secretory myeloma, a reduction of \>= 50% in size of soft tissue plasmacytomas. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * \< 5% plasma cells in the bone marrow. 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%. Calculated using Kaplan-Meier estimates.

    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).

  3. Time to Progression (TTP)

    Time to progression (TTP) was defined as the time from the date of first dose to the date of first documentation of progressive disease (PD). 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.

    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).

  4. Progression-free Survival (PFS)

    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.

    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).

  5. Overall Response Rate (ORR) Per Central Adjudication Committee

    Overall response rate (ORR) per Central Adjudication Committee is the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required

    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).

  6. Number of Participants With Adverse Events (AEs)

    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.

    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)

  7. Number of Participants With Serious Adverse Events (SAEs)

    A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

    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)

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

    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.

    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)

  9. Number of Participants With Adverse Events (AEs) Related to Study Drug

    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.

    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)

  10. Plasma Levels of ACY-1215 and Pomalidomide - Phase 1b

    Time frame: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8

  11. Number of Participants With Anti-Drug Antibodies (ADA) - Phase 1b

    Time frame: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8

07

Results

Posted Mar 4, 2025

Participant flow

Participant flow — Overall Study
MilestonePhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Started348511
Efficacy evaluable population34777
Safety population348511
Completed0000
Not completed348511
Withdrew: Lost to follow-up0010
Withdrew: Withdrawal by participant0081
Withdrew: Physician decision0030
Withdrew: Progressive disease34578
Withdrew: Other reasons0010
Withdrew: Adverse event00152

Outcome measures

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

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.

Time frame:
From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).
Reported as:
Number · mg/day
Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b
mg/dayPhase 1b - ACY-1215
Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b320
PrimaryOverall Response Rate (ORR) Per Investigator - Phase 2

Overall response rate (ORR) is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.

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).
Reported as:
Number · Percent of Participants
Overall Response Rate (ORR) Per Investigator - Phase 2
Percent of ParticipantsPhase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Overall Response Rate (ORR) Per Investigator - Phase 239.0 (28.0 to 50.8)71.4 (29.0 to 96.3)
SecondaryTime to Response (TTR)

Time to response (TTR) was defined as the time from first dose of study treatment to the first documentation of response (either partial response (PR) or complete response (CR)). CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.

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).
Reported as:
Mean · Weeks
Time to Response (TTR)
WeeksPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Time to Response (TTR)8.50 (4.1 to 12.9)—10.83 (4.1 to 40.1)12.96 (7.9 to 31.9)
SecondaryDuration of Response (DoR)

Duration of Response (DOR) was defined as the time from first partial response (PR) or complete response (CR) to the first documentation of progressive disease (PD) or death. PR: * \>= 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by \>= 90% or to less than 200 mg per 24 hours. * For non-secretory myeloma, a reduction of \>= 50% in size of soft tissue plasmacytomas. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * \< 5% plasma cells in the bone marrow. 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%. Calculated using Kaplan-Meier estimates.

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).
Reported as:
Median · Weeks
Duration of Response (DoR)
WeeksPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Duration of Response (DoR)20.10 (4.10 to 36.10)—30.30 (13.10 to 43.10)62.75 (54.75 to 121.6)
SecondaryTime to Progression (TTP)

Time to progression (TTP) was defined as the time from the date of first dose to the date of first documentation of progressive disease (PD). 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.

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).
Reported as:
Mean · Weeks
Time to Progression (TTP)
WeeksPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Time to Progression (TTP)22.43 (8.1 to 48.9)6.20 (4.1 to 8.1)29.82 (3.9 to 169.1)83.22 (7.7 to 183.1)
SecondaryProgression-free Survival (PFS)

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.

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).
Reported as:
Median · Weeks
Progression-free Survival (PFS)
WeeksPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Progression-free Survival (PFS)10.30 (8.10 to 48.90)6.30 (4.35 to 8.05)20.00 (9.10 to 41.60)62.70 (19.90 to 99.90)
SecondaryOverall Response Rate (ORR) Per Central Adjudication Committee

Overall response rate (ORR) per Central Adjudication Committee is the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required

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).

No measurements were reported for this outcome.

SecondaryNumber of Participants With Adverse Events (AEs)

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.

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)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Number of Participants With Adverse Events (AEs)348211
SecondaryNumber of Participants With Serious Adverse Events (SAEs)

A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

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)
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs)
ParticipantsPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Number of Participants With Serious Adverse Events (SAEs)02377
SecondaryNumber of Participants With Adverse Events (AEs) Leading to Discontinuation

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.

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)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
ParticipantsPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
ACY-121500131
Pomalidomide00131
Dexamethasone00161
SecondaryNumber of Participants With Adverse Events (AEs) Related to Study Drug

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.

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)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) Related to Study Drug
ParticipantsPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
ACY-121514639
Pomalidomide346211
Dexamethasone23579
SecondaryPlasma Levels of ACY-1215 and Pomalidomide - Phase 1b
Time frame:
Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8

No measurements were reported for this outcome.

SecondaryNumber of Participants With Anti-Drug Antibodies (ADA) - Phase 1b
Time frame:
Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8

No measurements were reported for this outcome.

Adverse events

Collected over Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 120 months). SAEs and Other AEs were assessed 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1b - ACY-1215 Dose Level 12/3 (66.7%)0/3 (0%)3/3 (100%)
Phase 1b - ACY-1215 Dose Level 31/4 (25%)2/4 (50%)4/4 (100%)
Phase 2 - ACY-1215 Dose Level 139/85 (45.9%)37/85 (43.5%)82/85 (96.5%)
Phase 2 - ACY-1215 Dose Level 33/11 (27.3%)7/11 (63.6%)11/11 (100%)
Most frequent serious events
Showing 10 of 69
Most frequent serious events
EventPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
Chest painGeneral disorders0/31/40/850/11
Drug hypersensitivityImmune system disorders0/31/40/850/11
PneumoniaInfections and infestations0/31/46/852/11
Confusional statePsychiatric disorders0/31/40/850/11
Atrial fibrillationCardiac disorders0/30/41/851/11
Cardiac failure chronicCardiac disorders0/30/40/851/11
BronchitisInfections and infestations0/30/41/851/11
Pneumonia parainfluenzae viralInfections and infestations0/30/40/851/11
Tumour lysis syndromeMetabolism and nutrition disorders0/30/40/851/11
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/30/43/851/11
Most frequent other events
Showing 10 of 177
Most frequent other events
EventPhase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3
DiarrhoeaGastrointestinal disorders0/34/432/856/11
Haemoglobin decreasedInvestigations3/30/40/853/11
ConstipationGastrointestinal disorders0/33/414/852/11
FatigueGeneral disorders2/32/449/858/11
Aspartate aminotransferase increasedInvestigations2/30/46/850/11
Neutrophil count decreasedInvestigations2/31/412/853/11
White blood cell count decreasedInvestigations2/30/44/854/11
HyponatraemiaMetabolism and nutrition disorders2/31/47/853/11
HypertensionVascular disorders2/30/42/854/11
AnaemiaBlood and lymphatic system disorders0/32/431/852/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3Total
<=18 years00000
Between 18 and 65 years2242450
>=65 years1243753
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3Total
Female2140447
Male1345756
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3Total
Hispanic or Latino00101
Not Hispanic or Latino34811199
Unknown or Not Reported00303
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1b - ACY-1215 Dose Level 1Phase 1b - ACY-1215 Dose Level 3Phase 2 - ACY-1215 Dose Level 1Phase 2 - ACY-1215 Dose Level 3Total
American Indian or Alaska Native00101
Asian00303
Native Hawaiian or Other Pacific Islander00000
Black or African American00718
White34721089
More than one race00000
Unknown or Not Reported00202
08

Study locations

2 sites
  • Local Institution - 201
    Boston, Massachusetts 02215, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 12, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01997840
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Nov 28, 2013
Start date
Mar 1, 2014
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024
Results posted
Mar 4, 2025
Last update
Mar 4, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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