ACTRN12613000219785已完成2 期
A 2-Stage Phase II study of panobinostat in myeloma patients with less than complete remission (CR) following high-dose chemotherapy conditioned autologous stem cell transplantation (ASCT).
The Alfred Hospital0 个研究点目标入组 25 人开始时间: 2013年2月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria at registration - pre-ASCT
- •1. Age > 18 years
- •2. Diagnosis of multiple myeloma
- •3. Must have been previously exposed to thalidomide, and/or lenalidomide and/or bortezomib containing induction regimen pre-ASCT (no more than 12 months total prior standard-dose chemotherapy)
- •4. No previous high-dose chemotherapy or ASCT
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •6. > 2 X 10^6 CD34+ stem cells available for infusion
- •7. Normal liver and kidney function (within 2 x the institutional upper limit of normal)
- •8. Written informed consent
- •Inclusion criteria to commence panobinostat post-ASCT
- •10. Have reached Day 42 post-ASCT with evidence of haematology recovery (neutrophils > 1.5 x 10^9/L, platelets unsupported > 50 x 10^9/L
- •11. Have failed to achieve CR and without progressive disease at 6 to 8 weeks post-ASCT
- •12. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •13. Normal liver and kidney function (within 2 x the institutional upper limit of normal); serum potassium, magnesium, phosphate, sodium, total corrected calcium within normal limits
排除标准
- •1. Patients with monoclonal gammopathy of uncertain significance (MGUS)
- •2. Patient has been treated with allogeneic transplant
- •3. Patient has received any anti-MM therapy after ASCT including but not limited to:
- •- chemotherapy prior to start of study
- •- biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
- •- radiation therapy
- •4. Patients with progressive MM post-ASCT
- •5. Patient has received prior treatment with DAC in ihibitors including panobinostat
- •6. Patient has received an investigational agent of any kind within 28 days of ASCT
- •7. Patient is taking any anti-cancer therapy concomitantly
- •8. Patient needs valproic acid within 5 days prior to first administration of panobinostat
- •9. Patients with evidence of another malignancy not in remission, or history of such a malignancy within the last 3 years (except for treated basal or squamous cell carcinoma,
- •or in situ cancer of the cervix)
- •10. Patient has undergone major surgery < 2 weeks prior to starting study drug or whohave not recovered from side effects of such therapy to < grade 1 CTCAE 4.0 or baseline
- •11. Patient has impaired cardiac function, including any one of the following:
- •- Left Ventricular Ejection Fraction < the lower limit of institutional norm
- •- Complete left bundle branch block, bifascicular block
- •- Obligate use of a permanent cardiac pacemaker
- •- Congenital long QT syndrome
- •- History or presence of ventricular tachy-arrhythmias
- •- Resting bradycardia defined as < 50 bpm
- •- QTcF > 480 msec on screening ECG
- •- Any clinically significant ST segment and/or T-wave abnormalities
- •- Presence of unstable atrial fibrillation (ventricular response rate > 100 bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria
- •- Myocardial infarction or unstable angina pectoris < 6 months prior to starting the study drug
- •- Congestive cardiac failure (New York Heart Association class III-IV)
- •- Other clinically significant heart disease and vascular disease (eg. uncontrolled hypertension)
- •12. Patient is taking medications with relative risk of prolonging the QT interval or inducing torsade de pointes, if such treatment cannot be discontinued or switched to a different medication prior to starting study drug
- •13. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat, such as:
- •- ulcerative disease
- •- uncontrolled nausea
- •- vomiting
- •- diarrhoea CTCAE 4.0 Grade > 2 (despite antidiarrheal medications)
- •- malabsorption syndrome
- •- obstruction
- •- stomach and/or small bowel resection
- •14. Patient has any other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol such as:
- •- uncontrolled diabetes
- •- active or uncontrolled infection
- •- chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause
- •- uncontrolled thyroid dysfunction
- •- recent, acute or active bleeding
- •15. Patient has a known history of human immunodeficiency virus (HIV) seropositivity or history of active/treated hepatitis B or C (a test for screening is not required)
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