EUCTR2006-004087-31-IT进行中（未招募）不适用
A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adults >=18 years old 2. Subjects must have signed the consent form before undergoing any study specific screening procedures and before participation in this study. The subject must be fully informed by the investigator of the nature and potential risks of participation in this study. 3. Diagnosis of symptomatic multiple myeloma (from IMWG see (Kyle et al,2003). All three of the following criteria must be met: ? Monoclonal immunoglobulin (spike on electrophoresis, or band on immunofixation) on serum or on 24 hour urine (or demonstration of M protein in cytoplasm of plasma cell for non secretory myeloma) . ? Bone marrow (clonal) plasma cells or plasmacytoma ? Related organ or tissue impairment (anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections) 4. Subjects must have received at least two prior lines of therapy and be refractory to the most recent line of therapy according to the following definitions: Refractory to most recent line of therapy Defined by disease progression during treatment or within 60 days after the completion of the most recent line of therapy. This includes the development of disease progression during maintenance or consolidation therapy with high dose glucocorticoids, or any other specific MM therapy At study screening, PD will be assessed by comparing screening values or symptoms in reference to the baseline (values or symptoms) of their last line of therapy . Should a patient have experienced an initial response on their last line of therapy, PD should be assessed in reference to the lowest values of the initial confirmed response (MR/PR/CR) Disease progression is defined by having one or more of the following: ? >25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. ? >25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. ? >25% increase in plasma cells in a bone marrow aspirate or on bone marrow biopsy, which must also be an absolute increase of at least 10%. ? Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. ? Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). ? Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). 5. Subjects must have previously been treated with bortezomib or lenalidomide 6. ECOG PS <= 2 7. All baseline studies must be performed within 21 days prior to first dose of LBH589 8. Patients must have the following hematological laboratory values: ? ANC >=1.5 x 109/L ? Hemoglobin >=8.0 g/dl ? Platelets >= 75.0 x 109/L 9. Patients must have adequate renal function as shown by : ? 24 -hour measured CrCl >= 50 mL/min, or if not available, by serum creatinine < 2 x ULN 10. Patients must have adequate liver function as shown by: ? AST and ALT <= 2.5 x ULN ? Serum bilirubin <= 1.5 x ULN ? Albumin >= 2.5 g/dl 11. Patients must have the following non-hematological laboratory values: ? Serum potassium >= LLN, ? Total serum calcium [corrected for serum albumin] or ionized calcium >=LLN, Serum magnesium >= LLN Serum phosphorus >=LLN Normal thyroid function (TSH and free T4) (hypothyroidism correctable with supp
排除标准
- •1. Prior therapy with an HDAC inhibitor 2. Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: ? Patients with congenital long QT syndrome ? History or presence of sustained ventricular tachyarrhythmia . (Patients with a history of atrial arrhythmia are eligible but should be discussed with the Sponsor prior to enrollment) ? Any history of ventricular fibrillation or torsade de pointes ? Bradycardia defined as HR< 50 bpm. Patients with pacemakers are eligible if HR >= 50 bpm. ? Screening ECG with a QTc > 450 msec ? Right bundle branch block + left anterior hemiblock (bifascicular block) ? Patients with myocardial infarction or unstable angina <= 6 months prior to starting study drug 3. Other clinically significant heart disease (e.g., CHF NY Heart Association class III or IV , uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) 4. Impairment of GI function or GI disease that may significantly alter the absorption of LBH589 5. Patients with unresolved diarrhea > CTCAE grade 1 6. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol 7. Patients using medications listed in Post-text supplement 1 that have a relative risk of prolonging the QT interval or inducing torsades de pointes if the medications cannot be discontinued or switched to a different medication prior to starting study drug 8. Concomitant use of CYP3A4 inhibitors (see Post-text supplement 1) 9. Patients with an active bleeding diathesis or on any treatment with therapeutic doses of sodium warfarin (Coumadin) or any other anti-vitamin K drug. Low doses of Coumadin (e.g., <=2 mg/day), or low doses of any other anti-vitamin K drug, for line patency is allowable 10. Patients who have received chemotherapy, radiation therapy or any investigational drugs, bortezomib or other immunomodulatory therapy (e.g., thalidomide, lenalidomide) or immunotherapy <= 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy 11. Patients who have received steroids (e.g., dexamethasone) <= 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy. Concomitant therapy medications that include corticosteroids are allowed if subjects receive < 10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products, while enrolled in this study.
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