ISRCTN08577602已完成2 期
A phase II trial of vorinostat in combination with bortezomib and dexamethasone in patients with relapsed and relapsed refractory multiple myeloma
niversity of Leeds (UK)0 个研究点目标入组 16 人开始时间: 2012年3月1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
- 16
研究概览
简要总结
2015 results in: www.bloodjournal.org/content/126/23/1852 2021 results in https://pubmed.ncbi.nlm.nih.gov/33478922/ (added 31/03/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able to give informed consent and willing to follow study protocol and quality of life assessments
- •2. Aged 18 years or over
- •3. Subjects with multiple myeloma diagnosed according to standard criteria, who require further treatment due to relapse or non-response after at least one but not more than three prior lines of treatment
- •4. Patients with measurable extramedullary plasmacytomas are allowed if they fulfil the above inclusion criteria
- •5. No prior Histone deacetylases (HDAC) inhibitor treatment. Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumour therapy must not be enrolled in this study. (Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enrol after a 30-day washout period.)
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
- •7. Required laboratory values within 21 days of registration
- •7.1. Absolute neutrophil count =1.0 x 109/L
- •7.2. Platelet count =75x109/L
- •7.3. Haemoglobin > 9 g/dL
- •7.4. Bilirubin =1.5 x upper limit of normal
- •7.5. ALT and / or AST =2.5 x upper limit of normal
- •7.6. Serum creatinine = 2.0 x upper limit of normal
- •7.7. Corrected calcium = 2.8 mmol/L
- •8. Life expectancy of at least 3 months
- •9. Female subjects of child-bearing potential must have a negative pregnancy test at baseline and agree to use dual methods of contraception for the duration of the study and must continue to do so for 3 months after the end of treatment. Male subjects must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of child-bearing potential and must continue to do so for 3 months after the end of treatment
- •10. Patient is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis
排除标准
- •1. Pregnant or breast feeding females
- •2. Previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 28 days before the start of protocol treatment. Steroid therapy to stop rapid relapse during this period is permitted, but must be stopped 7 days prior to study drug administration. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted.
- •3. Previous or concurrent active malignancies (<12 months post end of treatment) at other sites with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (=12 months) of other tumours may be entered
- •4. Patients considered to be refractory to prior bortezomib treatment (defined below) or unable to tolerate treatment with bortezomib.
- •4.1. Relapse on or within 60 days after the last dose of a bortezomib containing regimen
- •4.2. No clinical response (= SD/NC) on a bortezomib containing regimen
- •4.3. Peripheral neuropathy of = grade 2 severity
- •4.4. Patient has plasma cell leukaemia defined as the presence of more than 20% plasma cells in the peripheral blood and/or an absolute plasma cell count of = 2000/µL
- •4.5. Patient has uncontrolled concurrent illness or circumstances that could limit compliance with the study, including, but not limited to the following: acute or chronic graft versus host disease, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within past 6 months, uncontrolled cardiac arrhythmia, renal failure, psychiatric or social conditions that may interfere with patient compliance, or any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the patient at unacceptable risk for adverse outcome if he/she were to participate in the study.
- •4.6. Patients with significant cardiovascular disease (e.g. acute diffuse infiltrative pulmonary disease, pericardial disease, a history of congestive heart failure requiring therapy, presence of severe valvular heart disease, presence of an atrial or ventricular arrhythmia requiring treatment, uncontrolled hypertension, a history of QTc abnormalities or with QTC interval > 480 msecs
- •4.7. Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis
- •5. Unable to take corticotherapy at study entry
- •6. Patient with prior allogeneic bone marrow transplant
- •7. Patient has known hypersensitivity to any components of bortezomib, (such as boron, mannitol), or vorinostat
- •8. Patient has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- •9. Patient has a history of a gastrointestinal surgery or other procedures that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the study drug(s)
研究者
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