Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT02400242 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : May 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: ACY-241 Drug: Pomalidomide Drug: Dexamethasone | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma |
Actual Study Start Date : | May 7, 2015 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
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Experimental: ACY-241, Pomalidomide, and dexamethasone
Open label dosing cohorts will evaluate oral ACY-241 (dosing ranging from 180 mg to 480 mg days 1-21) in combination with oral pomalidomide (4 mg days 1-21), and oral dexamethasone (40 mg qd on days 1, 8, 15, 22).
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Drug: ACY-241
Dose escalation up to 480 mg administered orally on Days 1-21 of a 28 day cycle.
Other Name: Histone deacetylase inhibitor Drug: Pomalidomide 4 mg qd dosed on days 1-21 of a 28 day cycle
Other Name: immunomodulatory agent Drug: Dexamethasone 40 mg qd on days 1, 8, 15, 22
Other Name: corticosteriod |
- Maximum tolerated dose of ACY-241 as monotherapy as assessed by dose limiting toxicities [ Time Frame: Cycle 1 (28 days) ]
- Maximum tolerated dose of ACY-241 in combination with pomalidomide and low dose dexamethasone as assessed by dose limiting toxicities [ Time Frame: Cycle 2 (28 days) ]First cycle of combination therapy
- Frequency and severity of AEs as measured by safety and tolerability [ Time Frame: Cycle 1 (28 days) ]
- Single- and multiple-dose peak-plasma concentration [ Time Frame: Cycle 1 days 1, 2, 15 and 16 ]
- Single- and multiple-dose area under the plasma concentration versus time curve [ Time Frame: Cycle 1 days 1, 2, 15 and 16 ]
- Change in acetylation of histone and tubulin as a measure of pharmacodynamics [ Time Frame: Cycles 1 days 1, 2, 15, 16 and 22 ]
- Change in fetal hemoglobin expression as a measure of pharmacodynamics [ Time Frame: Cycles 1 days 1, 2, 15, 16 and 22 ]
- ACY-241 metabolite concentration in blood samples [ Time Frame: Cycles 1 days 1, 2, 15, 16 and 22 ]
- Exposure response analyses of potential biomarkers of response. [ Time Frame: Cycles 1 days 1, 2, 15, 16 and 22 ]
- Frequency and severity of AEs as measured by safety and tolerability in combination [ Time Frame: Beginning at Cycle 2 (28 day cycle each) until end of treatment ]
- Change in fetal hemoglobin expression as a measure of pharmacodynamics [ Time Frame: Cycle 2 days 1, 2, 15, 16 and 22 ]
- Change in acetylation of histone and tubulin as a measure of pharmacodynamics [ Time Frame: Cycle 2 days 1, 2, 15, 16 and 22 ]
- Single- and multiple-dose area under the plasma concentration versus time curve [ Time Frame: Cycle 2 days 1, 2, 15, and 16 ]
- Quantification of M-protein as a measure of anti-tumor activity [ Time Frame: Day 1 of each cycle beginning at Cycle 2 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Must have a documented diagnosis of MM and have relapsed or relapsed-and-refractory disease. All patients must have relapsed after having achieved at least stable disease (SD) for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease (PD). Relapsed-and-refractory patients also have documented evidence of PD during or within 60 days of completing last treatment
- Must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of proteasome inhibitor unless not a candidate.
- May have undergone prior treatment with pomalidomide if patient is not refractory to pomalidomide and has previously achieved a response of MR or better to pomalidomide.
- Must have measurable disease (serum M-protein or urine M-protein).
- Must have Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2.
- Must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
Key Exclusion Criteria:
- Prior therapy with pomalidomide with best response of PD or SD.
- Prior therapy with histone deacetylase (HDAC) inhibitor.
- Any of the following laboratory abnormalities: Absolute neutrophil count(ANC) < 1,000/µL, Platelet count < 75,000/µL or < 50,000/µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells, Hemoglobin < 8 g/dL, Creatinine clearance < 45 mL/min according to Cockcroft-Gault formula. If creatinine clearance calculated from the 24 hour urine sample is ≥ 45 mL/min, patient will qualify for the trial, Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3.0 × Upper Limited Normal (ULN), Serum total bilirubin > 2.0 mg/dL or > 3.0 × ULN for patients with hereditary benign hyperbilirubinaemia.
- Hematologic growth factors are not allowed at screening or during the first cycle of phase 1a or 1b.
- Nonsecretory myeloma or free light chain detected in serum only (ogliosecretory).
- Hypersensitivity to thalidomide, lenalidomide, pomalidomide, or dexamethasone
- Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400242

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT02400242 |
Other Study ID Numbers: |
ACE-MM-200 |
First Posted: | March 27, 2015 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | May 2022 |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Pomalidomide Histone Deacetylase Inhibitors Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors |