NCT00229203已完成2 期
"Phase II Multicenter, Open-Label, Clinical and Pharmacokinetic Study of Aplidin® As A 3-Hour Infusion Every 2 Weeks Alone or in Combination With Dexamethasone, in Pre-Treated Patients With Relapsing or Refractory Multiple Myeloma."
PharmaMar2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response
研究概览
简要总结
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM).
详细描述
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 h iv infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM) and to obtain the following :
- Additional pharmacokinetic information for Aplidin® given as 3-hour IV infusion every 2 weeks in patients with MM.
- To obtain additional genomic and pharmacodynamics information on MM and Aplidin.
- To assess the safety and tolerability of Aplidin® given as 3-hour IV infusion every 2 weeks in patients with MM alone or in combination with dexamethasone given orally as a 20 mg daily for 4 days
- To determine the response rate in the second cohort of patients following treatment with Aplidin®, given as a 3 hour infusion every 2 weeks, plus dexamethasone given orally as a 20 mg daily for 4 days, starting the same day of Aplidin® administration, as a second treatment stage in patients with suboptimal response to Aplidin® as single agent (progressive disease after three cycles or stable disease after four cycles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient before starting any study-specific procedure. If any patient is unable to give consent, it may be obtained from the patient's legal representative if in accordance with local laws and regulations
- •Age ≥ 18 years
- •Performance status Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •Life expectancy ≥ 3 months.
- •Patient was previously diagnosed with MM based on standard criteria and currently requires treatment because MM relapses following a response to standard chemotherapy or high-dose chemotherapy, or MM is refractory (i.e., failure to achieve at least complete response (CR), partial response (PR) or stable disease (SD)) to their most recent chemotherapy.
- •Patient has measurable disease, defined as follows:
- •For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.
- •For oligo or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. Magnetic resonance imaging (MRI), Computerized Axial Tomography (CT-Scan)).
- •Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade < 2 sensitive peripheral neuropathy is allowed.
- •Patient has the following laboratory values within 14 days before day 1, cycle 1:
- •Platelet count ≥ 50 x109/L, hemoglobin ≥ 8.0 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L; lower values may be accepted if clearly are due to bone marrow involvement by multiple myeloma.
- •Corrected serum calcium < 14mg/dL.
- •Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal.
- •Alanine transaminase (ALT): ≤ 2.5 x the upper limit of normal.
- •Total bilirubin: ≤ 1.5 x the upper limit of normal.
- •Calculated Creatinine clearance: ≥ 40 mL/minute (by means of Crockoft and Gault´s formula).
- •Left ventricular ejection fraction within normal limits.
排除标准
- •Prior therapy with Aplidin®.
- •Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception)
- •History of another neoplastic disease. The exceptions are:
- •non-melanoma skin cancer,
- •carcinoma in situ of uterine cervix,
- •any other cancer curatively treated and no evidence of disease for at least 10 years.
- •Other relevant diseases or adverse clinical conditions:
- •History or presence of unstable angina, myocardial infarction, valvular heart disease or congestive heart failure.
- •Previous mediastinal radiotherapy.
- •Uncontrolled arterial hypertension despite optimal medical therapy.
- •Previous treatment with doxorubicin at cumulative doses in excess of 400 mg/m².
- •Symptomatic arrhythmia or any arrhythmia requiring treatment.
- •History of significant neurological or psychiatric disorders
- •Active infection
- •Patient is known to be human immunodeficiency virus (HIV) positive, Hepatitis B surface antigen-positive or active hepatitis C infection.
- •Myopathy or any clinical situation that causes significant and persistent elevation of creatine kinase (CK)(>2.5 ULN in two different determinations performed with one week apart)
- •Significant non-neoplastic liver disease (e.g. cirrhosis, active chronic hepatitis)
- •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 months)
- •Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- •Treatment with any investigational product in the 30 days period before inclusion in the study or radiotherapy in the 4 weeks before inclusion in the study. Other previous treatments should have been completed 3 weeks before inclusion in the study, and in case of high dose chemotherapy, 8 weeks.
- •Known hypersensitivity to Aplidin®, mannitol, cremophor, or ethanol or dexamethasone.
结局指标
主要结局
Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response
时间窗: Every 2 weeks until progression or death occurs.
Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: \>25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. Treatmen failure: Reappearance of serum or urinary paraprotein
次要结局
- Time to Progression (TTP)(Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.)
- Progression Free Survival (PFS)(Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.)
- Number of Patients With Overall Survival (OS)(Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Clinical Trial of Aplidin® in Patients With Primary MyelofibrosisMyelofibrosisNCT01149681PharmaMar12
进行中（未招募）
不适用
Open-label, Phase II Clinical Trial of Aplidin (Plitidepsin) in Patients with Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia (Post-PV/ET) Myelofibrosis - ND- primary myelofibrosis (PMF), - post-polycythemia vera myelofibrosis (post-PV MF), or - post-essential thrombocythemia myelofibrosis (post-ET MF).MedDRA version: 9.1Level: LLTClassification code 10028537EUCTR2010-019790-15-ITPHARMA MAR45
终止
2 期
Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and LenalidomideMultiple MyelomaNCT03117361PharmaMar10
Unknown
2 期
OPTmizing Advanced Stage HodgkIn LymphoMa patIentS TherapyClassical Hodgkin LymphomaHodgkin Lymphoma (Category)Hodgkin DiseaseHodgkin LymphomaNCT03527628King Abdullah International Medical Research Center220
进行中（未招募）
2 期
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSLSecondary Central Nervous System LymphomaPCNSLNCT04438044Beijing InnoCare Pharma Tech Co., Ltd.61