Multiple Myeloma Clinical Trial

ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma

Summary

Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma.

Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have a documented diagnosis of multiple myeloma and have relapsed-and-refractory disease. Patients must have received at least 2 lines of prior therapies. Patients must have relapsed after having achieved at least stable disease (SD) for at least one cycle of treatment to at least one prior regimen and then developed progressive disease (PD). Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease)
Must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
Must not be a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT
Must have measurable levels of myeloma paraprotein in serum (≥ 0.5 g/dL) or urine (≥ 0.2 g/24 hours)
Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to, and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods,and Education and Counseling Guidance must be followed per protocol
Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3

Exclusion Criteria:

Pregnant or lactating females
Prior therapy with HDAC inhibitor

Any of the following laboratory abnormalities:

ANC < 1,000/µL
Platelet count < 75,000/ µL for patients in whom < 50% of bone marrow nucleated cells are plasma cells; and < 50,000/ µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
Hemoglobin < 8g/dL (<4.9 mmol/L; prior red blood cell [RBC] transfusion is permitted)
Creatine clearance < 45mL/min according to Cockcroft-Gault formula. If creatine clearance calculated from the 24-hour urine sample is ≥ 45 mL/min, patient will qualify for the study
Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), or serum glutamic pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT) > 3.0 × ULN
Serum total bilirubin > 2.0 mg/dL

Prior history of malignancies, other than MM, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:

Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix or breast
Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
Corrected QT interval using Fridericia's formula (QTcF) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG)
Positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (such as Steven Johnson Syndrome). Hypersensitivity, such as rash, that can be medically managed is allowable
Peripheral neuropathy ≥ Grade 2 despite supportive therapy
Radiotherapy or systemic therapy (standard or an investigational or biologic anticancer agent) within 14 days of initiation of study drug treatment
Current enrollment in another clinical trial involving treatment and/or is receiving an investigational agent for any reason
Inability or unwillingness to comply with birth control requirements or regional REMS/RevAid programs

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

103

Study ID:

NCT01997840

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There is 1 Location for this study

See Locations Near You

Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Horizon Oncology Center
Lafayette Indiana, 47905, United States
Local Institution - 207
Lafayette Indiana, 47905, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Univesity of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Local Institution - 209
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Local Institution - 213
Hawthorne New York, 10532, United States
New York Medical College
Hawthorne New York, 10532, United States
Mt. Sinai Medical Center Division of Hematology/Oncology
New York New York, 10029, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University Arthur G. James Cancer Hospital
Columbus Ohio, 43210, United States
Local Institution - 210
Pittsburgh Pennsylvania, 15232, United States
University of Pittsburgh Medical Center - Cancer Pavilion
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 212
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Local Institution - 301
Toronto Ontario, M5G 2, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Alexandra Hospital, University of Athens
Athens , 11528, Greece
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino , 01012, Italy
Local Institution - 320
Torino , 01012, Italy

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

103

Study ID:

NCT01997840

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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