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



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:May 7, 2015
End Date:July 30, 2019

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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

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).

During phase 1a, patients will receive 1 cycle of ACY-241 monotherapy. Patients who complete
the ACY-241 monotherapy cycle without a dose limiting toxicity (DLT) and are clinically
stable may continue to phase 1b combination therapy, beginning with Cycle 2. During phase 1b,
patients will receive ACY 241 in combination with pomalidomide and low dose dexamethasone at
the currently approved pomalidomide dose and schedule. Each cohort of patients in phase 1a
and phase 1b will consist of at least 3 patients. The first patient enrolled in each cohort
of phase 1a will be observed for 1 week before enrollment of subsequent patients in the
cohort. Patients who withdraw consent before entering phase 1b will be replaced. (Replacement
patients must complete phase 1a prior to continuing to phase 1b.) Patients who experience a
DLT or other unacceptable toxicity in Cycle 1 of phase 1a monotherapy or Cycle 2, the first
cycle of phase 1b combination therapy, will be removed from study treatment. An assessment of
the safety of treatment will be completed by the Safety Review Committee (SRC) prior to
dose-escalation.

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
We found this trial at
12
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Noopur Raj, MD
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Miami, Florida 33136
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Miami, FL
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Canton, OH
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Denver, CO
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Lille,
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New York, New York 10021
Principal Investigator: Rueben Niesvizky, MD
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New York, NY
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San Antonio, TX
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Seattle, Washington 98104
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Tampa, Florida 33612
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Amit Agarwal, MD, PhD
University of Arizona The University of Arizona is a premier, public research university. Established in...
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