Overview

Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma

Status:
Active, not recruiting
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Acetylon Pharmaceuticals Incorporated
Celgene
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Histone Deacetylase Inhibitors
Pomalidomide
Thalidomide
Criteria
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