Multiple MyelomaPhase 1/2NCT01997840
ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
A Phase 1/2 study testing ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2014to 29 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 201
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: A Phase 1B/2 Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (RICOLINOSTAT) in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
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
- Conditions
- Multiple Myeloma
- Being tested
- ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone
- Keywords
- Multiple Myeloma, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Blood Protein Disorders, Hematologic Diseases, Dexamethasone, Dexamethasone acetate, Pomalidomide
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Blood Protein Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasoneDrug
Also called Pomalyst, Ricolinostat, 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
| Study group | Role | What they receive |
|---|---|---|
| ACY-1215 in combination with pomalidomide and dexamethasone | Experimental | ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone Receives: Drug: ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).
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.
Measured: 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 (11)
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.
Measured: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
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.
Measured: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
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.
Measured: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
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.
Measured: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
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
Measured: From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Plasma Levels of ACY-1215 and Pomalidomide - Phase 1b
Measured: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8
Number of Participants With Anti-Drug Antibodies (ADA) - Phase 1b
Measured: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study start1 Mar 2014
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Why it stopped: Change in business priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997840
- Sponsor's protocol ID
- ACE-MM-102
- Status last verified
- Feb 2025
- First submitted
- 20 Nov 2013
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B/2 Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (RICOLINOSTAT) in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01997840
- Acronym / sponsor ID
- ACE-MM-102
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Blood Protein Disorders, Hematologic Diseases, Dexamethasone, Dexamethasone acetate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in business priorities.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACY-1215 in combination with pomalidomide and dexamethasone | Experimental | Drug: ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasoneACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- Pregnant or lactating females
- Prior therapy with HDAC inhibitor
- Any of the following laboratory abnormalities:
- Prior history of malignancies, other than MM, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasoneAlso: Pomalyst, Ricolinostat, DexamethasoneACY-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 | Drug | ACY-1215 in combination with pomalidomide and dexamethasone |
Primary outcome
Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b
Time frame: From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).
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.
Overall Response Rate (ORR) Per Investigator - Phase 2
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).
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.
11 secondary outcomes
Time to Response (TTR)
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).
Duration of Response (DoR)
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).
Time to Progression (TTP)
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).
Progression-free Survival (PFS)
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).
Overall Response Rate (ORR) Per Central Adjudication Committee
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).
Number of Participants With Adverse Events (AEs)
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)
Number of Participants With Serious Adverse Events (SAEs)
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)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
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)
Number of Participants With Adverse Events (AEs) Related to Study Drug
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)
Plasma Levels of ACY-1215 and Pomalidomide - Phase 1b
Time frame: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8
Number of Participants With Anti-Drug Antibodies (ADA) - Phase 1b
Time frame: Cycle 1 day 1, Cycle 1 Day 2, Cycle 1 Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of ACY-1215- Phase 1b (time frame: From first dose until the end of Phase 1b (up to a maximum of approximately 50 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.