EUCTR2014-002740-41-ES进行中（未招募）1 期
Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in combination with Pomalidomide and Dexamethasone for relapsed/refractory MM patients - POMDEFI
Fundación Pethema0 个研究点目标入组 24 人开始时间: 2014年11月25日最近更新:
适应症
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
- 24
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.Age ?18 years.
- •2.Performance status (ECOG) ? 2.
- •3.Patient is, in the Investigator's opinion, willing and able to comply
- •with the protocol requirements.
- •4.Patient has given voluntary written Informed Consent before
- •performance of any study-related procedure not part of normal medical
- •care, with the understanding that consent may be withdrawn by the
- •patient at any time without prejudice to their future medical care.
- •5.Patients previously diagnosed with MM according to the IMWG Criteria
- •(Blood 2011) that after previous treatment with one or more regimens
- •require therapy due to a relapse/progression of the disease.
- •6.Regarding the disease history, patient must:
- •a.Have received 2 prior lines of therapy including bortezomib and
- •lenalidomide.
- •b.Be refractory or intolerant to lenalidomide.
- •c.Be refractory to the last line of therapy.
- •(Refractoriness to any therapy is defined as either failure to achieve
- •minimal response with it, or development of progressive disease (PD)
- •while on therapy or within 60 days after finishing it.
- •At least two cycles of treatment must have been received, unless PD is
- •documented earlier.)
- •7.Only for the Phase II, patients must have measurable disease, defined
- •as any of the following:
- •a.Serum monoclonal protein value ? 500 mg/dl.
- •b.Urine light chain excretion ? 200 mg/24 hours.
- •c.Abnormal serum free light chains (FLCs) plus involved FLC level
- •? 10 mg/dl.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Prior therapy with Filanesib or pomalidomide.
- •2.Non-adequate hematological or biochemical parameters as specified
- •a.Hemoglobin < 8.0 g/dl.
- •b.Platelets count < 75 x109/L without previous platelet
- •transfusions in the last 7 days. If high bone marrow infiltration (>50%)
- •is present, ? 50 x109/L platelet count is required.
- •c.Neutrophils (ANC) <1.5 × 109/L without growth factor support
- •(defined as no growth factor administration for at least 14 days prior to
- •observation). If the bone marrow contains ? 50% plasma cells, a
- •neutrophil count ?1.0 × 109/L is allowed.
- •d.Aspartate transaminase (AST): > 2.5 x the upper limit range.
- •e.Alanine transaminase (ALT): > 2.5 x the upper limit range.
- •f.Total bilirubin: > 2 x the upper limit range.
- •g.Creatinine clearance: < 45 mL/min (measured or calculated
- •with the Cockcroft and Gault formula).
- •3.Absence of recovery from any significant non-hematological toxicity
- •derived from previous treatments. The presence of alopecia and NCI-CTC
- •grade < 2 symptomatic peripheral neuropathy is allowed.
- •4.Concomitant anti-myeloma therapy, including corticosteroids at a dose
- •greater than 10 mg/d prednisone or equivalent, within 14 days prior to
- •Day 1 of Cycle 1.
- •5.Pregnant or lactating women; men and women of reproductive
- •potential who are not using effective contraceptive methods (double
- •barrier method, intrauterine device, oral contraception).
- •6.Previous history of any other neoplastic disease in the last five years
- •(except basal cell carcinoma, skin epithelioma or carcinoma in situ of
- •7.Other relevant diseases or adverse clinical conditions:
- •a.Congestive heart failure or angina pectoris, myocardial
- •infarction within 12 months before inclusion in the study.
- •b.Uncontrolled arterial hypertension or cardiac arrhythmias (i.e.
- •requiring a change in medication within the last 3 months or a hospital
- •admission within the past 6 months).
- •c.History of significant neurological or psychiatric disorders.
- •d.Active infection.
- •e.Significant non-neoplastic liver disease (e.g., cirrhosis, active
- •chronic hepatitis).
- •f.Uncontrolled endocrine diseases (e.g. diabetes mellitus,
- •hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in
- •medication within the last month, or hospital admission within the last 3
- •8.Patient is known to be human immunodeficiency virus (HIV) positive,
- •Hepatitis B surface antigen-positive or active hepatitis C infection.
- •9.Limitation of the patient's ability to comply with the treatment or
- •follow-up protocol.
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