Multiple Myeloma Clinical Trial

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

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).

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02400242

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 17 Locations for this study

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University of Arizona
Tucson Arizona, 85719, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
University of Miami Medical Center
Miami Florida, 33136, United States
Local Institution - 108
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Local Institution - 103
Atlanta Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Local Institution - 101
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
CTRC at The UT Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Local Institution - 111
Seattle Washington, 98104, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille , 59037, France
Local Institution - 340
Lille , 59037, France
Hotel Dieu CHU Nantes
Nantes Cedex 01 , 44093, France
Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato
Heidelberg , 69120, Germany
Alexandra Hospital, University of Athens
Athens , 11528, Greece
Clinica Universitaria de Navarra
Pamplona , 31008, Spain
Local Institution - 301
Pamplona , 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Local Institution - 300
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02400242

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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