EUCTR2012-000842-36-GB进行中（未招募）1 期
A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients - MUK six
niversity of Leeds0 个研究点目标入组 57 人开始时间: 2012年5月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
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
入选标准
- •Patients with a previous diagnosis of multiple myeloma based on IMWG 2003 definitions:
- •o Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation of serum or of total 24 hour urine
- •o Bone marrow (clonal) plasma cells =10% or biopsy proven plasmacytoma
- •o Related organ or tissue impairment (CRAB symptoms, anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)
- •Relapsed or relapsed-and-refractory myeloma who have received 1-4 prior lines and now require further treatment
- •Able to give informed consent and willing to follow study protocol
- •Aged 18 years or over
- •ECOG Performance Status = 2
- •Required laboratory values within 14 days of registration:
- •o Absolute neutrophil count = 1.0 x 109/L. Growth factor support is not permitted within 14 days prior to eligibility assessment
- •o Platelet count = 100 x 109/L. Platelet support is not permitted within 14 days prior to eligibility assessment
- •o Haemoglobin = 8.0g/dL. Blood transfusion support is permitted
- •o Bilirubin = 2 x upper limit of normal (ULN)
- •o AST and/or ALT = 2.5 x ULN; except in subjects with known hepatic involvement, where AST and/or ALT = 5.0 x ULN
- •o Serum creatinine = 2.0 x ULN
- •o Corrected calcium = 2.8 mmol/L.
- •Anticipated survival of at least 3 months
- •Evaluable disease per modified IWG criteria, utilising the following assessments as appropriate:
- •o Serum M protein = 10g/l.
- •o Urine M protein = 200mg/24 hours
- •o Serum free light chain assay: involved FLC level = 100mg/l. Provided serum FLC ratio is abnormal
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •Pregnant (positive pregnancy test) or breastfeeding women.
- •Non-secretory multiple myeloma
- •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 is permitted (maximum 160mg dexamethasone or equivalent), but must be stopped 48 hours prior to study drug administration. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted.
- •Concurrent or previous malignancies (<12 months post end of treatment) at other sites with the exception of appropriately treated localised epithelial skin or cervical cancer, or incidental histologic findings of prostate cancer (TMN stage T1a or 1b). Patients with histories (=12 months) of other tumours may be entered.
- •Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical study
- •Patients with significant cardiovascular disease (e.g. 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)
- •Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis.
- •Gastrointestinal disorders that may interfere with absorption of the study drug
- •Patients who have been refractory to prior bortezomib, i.e. did not achieve at least an MR, or who have progressed on therapy or within 60 days of last dose
- •Participants with peripheral neuropathy CTC grade 2 or higher or grade 1 with pain within 14 days prior to registration
- •Any history of known hypersensitivity to any of the study medication or excipients
研究者
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