EUCTR2017-000586-72-DK进行中（未招募）1 期
KRd consolidation in myeloma patients with a positive PET-CT after standard first line treatment. A phase II study
Oslo University Hospital0 个研究点目标入组 50 人开始时间: 2017年11月14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
- 50
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
- •Each patient must meet all the following inclusion criteria to be enrolled in the study:
- •1. At least 18 years of age, with at least 6 months expected survival.
- •2. Prior confirmed diagnosis of multiple myeloma (2014) (16).
- •3.Received standard first line treatment with at least a very good partial response (VGPR), according to IMWGs criteria . Standard first line treatment is defined as
- •VRD, VTD or VCD followed by ASCT with or without lenalidomide maintenance initiated (Patients where the monoclonal component or dFLC increases during the period from best response to screening can be included if there is no progressive disease.)
- •4.Patients must be carfilzomib naïve.
- •5.A positive PET-CT result from central reviewer in the screening period
- •6. Successful FISH evaluation performed with available results
- •7. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
- •8. Females of childbearing potential (FCBPs) must have a confirmed negative serum pregnancy test within the 7 days prior to inclusion
- •9.of contraceptive during the study and for 30 days following the last study drug dose. Male subjects must use contraception and refrain from donating sperm for at least 90 days after the last dose of carfilzomib.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. In patients >75 years of age, performance status 0-1.
- •11.Patients must meet the following adequate organ and bone marrow function within 21 days prior to inclusion:
- •Absolute neutrophil count (ANC) = 0,5 x 109/L) and platelet count 35 x 109/L. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. Granulocyte growth factors are allowed to meet the inclusion criteria.
- •12. Patient must be willing and able to adhere to the study schedule and other protocol requirements.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Change of first line treatment because of stable or progressive disease.
- •2. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- •3. Major surgery within 28 days before enrollment.
- •4. Radiotherapy within 14 days before enrollment. Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
- •5. Patients who started treatment more than 12 month before screening
- •6. Central nervous system involvement.
- •7. Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
- •8. Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
- •9. Any other serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
- •10. Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) or to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- •11. Contraindication to dexamethasone or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- •12. Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •13. Patients that have previously been treated with carfilzomib.
- •14. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome.
- •15. Pleural effusions requiring thoracocentesis within the 14 days prior the inclusion.
- •16. Ascites requiring ascites puncture within the 14 days prior to inclusion.
- •17. Previous allogeneic transplantation
- •18. Uncontrolled hypertension or uncontrolled diabetes despite medication
- •19. Contraindication to PET-CT
- •20. Not expected to tolerate full dose KRd
研究者
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