Clinical trial · Interventional
Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor activity of ACY-241 for oral administration as monotherapy and in combination therapy with orally administered pomalidomide and low-dose dexamethasone in eligible patients with relapsed or relapsed-and-refractory multiple myeloma (MM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACY-241 | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ACY-241, Pomalidomide, and dexamethasone
- description
- 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).
- interventionNames
- Drug: ACY-241
- Drug: Pomalidomide
- Drug: Dexamethasone
Primary outcomes (2)
- measure
- Maximum tolerated dose of ACY-241 as monotherapy as assessed by dose limiting toxicities
- timeFrame
- Cycle 1 (28 days)
- measure
- Maximum tolerated dose of ACY-241 in combination with pomalidomide and low dose dexamethasone as assessed by dose limiting toxicities
- timeFrame
- Cycle 2 (28 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available