EUCTR2015-003486-29-FR进行中（未招募）1 期
Phase II Trial of Plitidepsin (Aplidin®) in Combination with Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to bortezomib and lenalidomide .
Pharma Mar, S.A.0 个研究点目标入组 64 人开始时间: 2017年1月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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)Patients must give written informed consent (IC) in accordance with institutional and local guidelines.
- •2)Age = 18 years.
- •3)Patients must have a confirmed diagnosis of MM according to the Durie and Salmon criteria.
- •4)Patients must have measurable disease defined as any of the following:
- •a)Serum M-protein = 0.5 g/dL or = 0.2 g/24-h urine light chain (UFLC) excretion.
- •b)In patients who lack measureable M-protein in serum or urine, i.e., serum M-protein < 0.5 g/dL and urine M-protein < 0.2 g/24 h, serum free light chain (SFLC) levels are most informative. SFLC levels can be used only if the baseline SFLC ratio is abnormal (<0.26 or >1.65), indicating clonality. In addition, the baseline SFLC level must be =10 mg/dl of the appropriate involved light chain isotype.
- •c)When applicable, measurable soft tissue plasmacytoma = 2 cm, by either physical examination and/or applicable radiological evaluation (i.e., magnetic resonance imaging [MRI], computed tomography [CT]-scan).
- •5)Prior autologous and/or allogeneic hematopoietic stem cell transplantation (HSCT) patients are allowed. Patients must not have acute/chronic graft-versus-host disease (GVHD) or be receiving immunosuppressive therapy at least 90 days before the onset of treatment with the trial drug(s).
- •6)Patients must have received previous treatment with bortezomib and lenalidomide and be refractory to both.
- •7)Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2.
- •8)Recovery to grade = 1 from any non-hematological adverse event (AE) derived from previous treatment (if present, alopecia and peripheral neuropathy must be grade <1).
- •9)Laboratory data:
- •a)Hemoglobin = 8 g/dL.
- •b)Absolute neutrophil count (ANC) = 1,000 cells/mm3 (1.0 x 109/L) (= 0.5 x 109/L if due to extensive bone marrow [BM] involvement by = 50% of plasma cells in BM biopsy). Screening of ANC should be independent of granulocyte- and granulocyte/macrophage-colony stimulating factor (G-CSF and GM-CSF) support for at least one week and of pegylated G-CSF for at least two weeks.
- •c)Platelet count = 50,000/mm3 (50.0 x 109/L) for patients in whom < 50% of the BM nucleated cells are plasma cells.
- •d)Platelet count = 25,000/mm3 (25.0 x 109/L) for patients in whom = 50% of BM nucleated cells are plasma cells.
- •e)Serum total bilirubin < 1.5 x institutional upper limit of normal (ULN) (except when Gilbert syndrome is clearly documented and other liver function tests are within normal levels).
- •f)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and = 3.0 x institutional ULN and alkaline phosphatase (AP) = 2.5 x institutional
- •g)Creatinine clearance (CrCl) > 30 mL/min, measured or calculated according to Cockcroft and Gault’s formula.
- •h)Albumin = 2.5 g/dl.
- •10)Evidence of non-childbearing status for women of childbearing potential (WOCBP): WOCBP must have a negative serum or urine pregnancy test within seven days prior to enrolment and must agree to use a highly effective contraceptive measure throughout the trial and during six months after treatment discontinuation. Male patients enrolled in the study should also use contraceptive methods during and after treatment discontinuation.
- •11)Left ventricular ejection fraction (LVEF) = 45%.
- •12)Patients must have a BM assessment within three weeks prior to enrolment.
- •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 r
排除标准
- •1)Previous treatment with plitidepsin.
- •2)Active or metastatic primary malignancy other than MM.
- •3)Serious concomitant systemic disorders that would compromise the safety of the patient or the patient’s ability to complete the trial, including the following specific conditions:
- •a)Uncontrolled psychiatric illness or medical illness that the Investigator feels will compromise the patient’s tolerance of the trial medication.
- •b)Significant non-neoplastic liver disease.
- •c)Uncontrolled endocrine diseases (i.e., requiring relevant changes in medication within the last month, or hospital admission within the last three months).
- •d)Uncontrolled systemic infection.
- •e)Acute infiltrative pulmonary and pericardial disease.
- •4)Other relevant cardiac conditions:
- •a)Symptomatic arrhythmia (excluding anemia-related grade = 2 sinusal tachycardia) or any arrhythmia requiring ongoing treatment, and/or prolonged grade = 2 QT-QTc; or presence of unstable atrial fibrillation (according to the National Cancer Institute Common Terminology Criteria for the Classification of Adverse Events [NCI-CTCAE] v4.0). Patients on treatment for stable atrial fibrillation are allowed, provided they do not meet any other cardiac or prohibited drug exclusion criterion.
- •b)History or presence of unstable angina, myocardial infarction, valvular heart disease, cardiac amyloidosis or congestive heart failure within the last 12 months.
- •c)Uncontrolled arterial hypertension (= 150/100 mmHg) despite optimal medical therapy.
- •d)Previous treatment with doxorubicin at cumulative doses of
- •> 400 mg/m², or equivalent.
- •5)History of hypersensitivity reactions and/or intolerance to bortezomib, polyoxyl 35 castor oil, mannitol, boron or dexamethasone.
- •6)Myopathy or any clinical situation that causes significant and persistent elevation of creatine phosphokinase (CPK) (> 2.5 ULN) in two different determinations performed within one week of each other.
- •7)Grade = 1 neuropathy (either bortezomib-related or not) according to NCI-CTCAE v4.0.
- •8)Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the patients’ participation in this trial.
- •9)Pregnant and/or lactating women.
- •10)Known active human immunodeficiency virus (HIV) infection (HIV testing is not required unless infection is clinically suspected).
- •11)Active hepatitis B or C virus (HBV or HCV) infection.
- •12)Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the trial.
- •13)Concomitant medications that include corticosteroids, chemotherapy (CT), or other therapy that is or may be active against myeloma. Concurrent corticosteroids are allowed as an equivalent to a prednisone dose of = 10 mg daily, administered as an antiemetic or as premedication for blood products.
- •14)Wash-out periods after the end of the previous therapy:
- •a)Nitrosoureas must be discontinued six weeks prior to Cycle (C) 1, D1.
- •b)Thirty days for other CTs and 15 days for other biological agents prior to C1 D1.
- •c)Thirty days after the end of any prior radiation or radionuclide therapy (six weeks in the case of prior extensive external beam radiation, with more than 25% of BM distribution).
- •15)Plasma cell leukemia at the time of trial entry.
- •16)Disease-related symptomatic hypercalcemia despite optimal medical therapy.
- •17)Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
- •18)Contraindication to use steroids.
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