ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01997840
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-557
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
Massachusetts General Hospital, Dana-Farber Cancer Institute
Noopur Raje, MD,
Massachusetts General Hospital
Paul Richardson, MD,
Dana-Farber Cancer Institute
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Kathleen Colson, 617-632-6303,
- 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
- 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,
- 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. See Appendix 9.3.1 Risks of Fetal Exposure, Pregnancy Testing
Guidelines and Acceptable Birth Control Methods, AND also Appendix 9.3.2 Education
and Counseling Guidance Document.
- 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.
- 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; or a platelet count < 30,000/ µL for patients in whom ≥
50% of bone marrow nucleated cells are plasma cells
- Serum creatinine ≥ 3.0 mg/dL
- 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
and pre-dose on C1D1; 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).
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C
virus (HCV) infection.
- Hypersensitivity to thalidomide, lenalidomide, or dexamethasone.
- Peripheral neuropathy ≥ Grade 2.
- 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.