ACY-1215 in Combination With Lenalidomide, and Dexamethasone for Multiple Myeloma
A Phase 1, Open Label, Multicenter Study of ACY-1215 in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma
|Closed||Multiple Myeloma||Phase I||NCT01583283|
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.
Eligibility Criteria (must meet the following to participate in this study)
- 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.
Exclusions (conditions that would prevent participation in this study)
- 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.
Last UpdatedOctober 14, 2015
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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