EUCTR2015-004530-94-ES进行中（未招募）1 期
Pilot study (Phase II) of Pomalidomide, oral Desamethasone and very low-dose Cyclophosphamide in patients with refractory Multiple Myeloma who have received Lenalidomide and Bortezomib. - FCO-PDC-2015-01
Fundación para la investigación biomédica de Córdoba0 个研究点目标入组 20 人开始时间: 2016年2月17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
- 20
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
- •1. Subject older than 18 years meeting criterion 2 or 3.
- •2. Subject diagnosed of multiple myeloma.
- •3. Patients with symptomatic multiple myeloma relapsed / refractory after receiving at least two treatment cycles including Bortezomib and at least two cycles that include Lenalidomide, combined in the same therapeutic regimen or as part of different chemotherapy regimens.
- •a) Clinical and / or biological relapse : Patients must have received at least two prior lines of treatment and have relapsed after obtaining at least stable disease for at least one cycle of each of the chemotherapy regimens received before they developed progression of the disease.
- •i. Clinical relapse: Defined according to the International Myeloma Working Group (IMWG) criteria.
- •ii. Biological Relapse y: They are defined according to the International Myeloma Working Group (IMWG) criteria.
- •b) Refractory disease: In this case, patients should have progressed on a processing line or within 60 days after completion before inclusion.
- •4. Patients with multiple myeloma with measurable disease, defined as the presence of monoclonal component of at least 0.5 g / dL in serum or at least 0.2 g / d in urine, or in those without measurable disease radio presence altered light chain at the time of study entry.
- •5. Patients with good performance status ECOG defined as ? 2.
- •6. Signature of informed consent.
- •7. The patient should be able to meet all scheduled visits and other requirements.
- •8. Laboratory analysis: Patients must have:
- •a) absolute neutrophil: ?1000 / uL
- •b) Platelet Count: ?50.000 / uL
- •c) Hemoglobin:> 8 g ??/ dL
- •d) Total bilirubin <2 x upper normal limit
- •e) AST and ALT: <3 x upper normal limit
- •f) serum potassium: within normal limits.
- •9. Childbearing potential women should have a negative pregnancy test.
- •10. The male patient included in the trial must commit to always use latex condom during any sexual contact with women of childbearing age, even if he has undergone a vasectomy successfully.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Any concomitant diseases, abnormal laboratory or psychiatric disorder that can assume inability of the subject to sign the IC.
- •2. PS> 3 on the ECOG scale.
- •3. Previous history of non-hematologic neoplasia, unless the patient has been free of the disease for ? 5 years. Exceptions include the following:
- •a. basal cell skin carcinoma
- •b. squamous cell skin carcinoma
- •c. In situ cervical carcinoma
- •d. In situ breast carcinoma
- •4. Patients who are unable or unwilling to undergo an antithrombotic therapy.
- •5. Positive serology known for HIV or HIV active infectious hepatitis, type B, or C.
- •6. Depressed cardiac function or clinically significant cardiac disease
- •7. Severe hypercalcemia
- •8. Major surgery within 15 days prior to the inclusion or not having recovered from its side effects.
- •9. Any serious medical condition, including laboratory abnormalities that make the patient to take an unacceptable risk if he participates in this study or that may interfere with the interpretation of the trial data.
- •10. Patients treated with any investigational drug within the previous 28 days.
- •11. Any severe medical condition, abnormality in laboratory tests or any psychiatric illness that prevented the signing of written consent.
- •12. Pregnant women or breast-feeding.
- •13. Hypersensitivity to drugs or compounds or biological composition similar to study chemistry.
- •14. Plasma Cell Leukemia.
研究者
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