Study of ACY-1215 in Combination With Lenalidomide, and Dexamethasone in Multiple Myeloma

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01583283 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-191

 

The purpose of this study is to determine the best dose of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Once determined, the purpose of this study will be to determine the efficacy of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma who have had 1-3 prior therapies and who are not lenalidomide-refractory.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Anuj Mahindra, M.D., Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Relapsed or Relapsed/Refractory MM with progressive disease (PD) according to IMWG. - Received at least 1 prior line of therapy for MM - Not a candidate for autologous stem cell transplant (ASCT) or declined option. - Karnofsky Performance Status score ≥ 70 - Adequate bone marrow reserve as evidenced by ANC > 1.0x109/L;Platelet > 50x109/L - Creatinine Clearance of ≥ 60 mL/min - Adequate hepatic function as evidenced by serum bilirubin values < 2.0 mg/dL; ALT and/or AST < 3xULN. - Corrected serum calcium ≤ ULN - Able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Coumadin will be allowed provided the patient is fully anticoagulated, with an INR of 2 or 3. - Agreement to participate in RevAssist® Program - Female of childbearing potential must have a negative pregnancy test 10-14 days prior to and again within 24 hours of prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence or begin TWO acceptable methods of birth control. - If male, including those who have had a vasectomy, must agree to use a latex condom during any sexual contact with a female of childbearing potential. Exclusion Criteria: - Received any of the following antitumor therapies - Radiotherapy or systemic therapy within 2 weeks of Cycle 1 Day 1 (C1D1) - Investigational or biologic therapies within 3 weeks of C1D1 - Prior peripheral ASCT within 12 weeks of C1D1 - Prior allogeneic stem cell transplant - Prior treatment with a histone deacetylase (HDAC) inhibitor - Presence of an active systemic infection requiring treatment. - History of other malignancies unless the patient has undergone definitive treatment more than 5 yr prior, excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with current prostat specific antigen < 0.1 ng/mL; ductal carcinoma in situ; or cervical intraepithelial neoplasia. - Known or suspected human immunodeficiency virus (HIV), hepatitis B surface antigen-positive status or known or suspected active hepatitis C. - History of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness including but not limited to congestive heart failure (NYHA Class 3 or 4), unstable angina; cardiac arrhythmia, recent(within past 6 months) myocardial infarction or stroke; uncontrolled hypertension; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months, COPD requiring > 2 hospitalizations in preceding 12 months - QTcF > 480 msec, family or personal history of long QTc syndrome or ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for medications known or suspected of producing prolonged QTc intervals on ECG - Documented plasma cell leukemia or known amyloidosis. - Known hypersensitivity to thalidomide or lenalidomide. - History of erythema nodosum characterized by desquamating rash while taking thalidomide or similar drugs.
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