EUCTR2016-001178-13-FI进行中（未招募）1 期
Phase 2 study of carfilzomib + elotuzumab + dexamethasone for relapsed or progressed multiple myeloma after 1-3 prior treatment lines
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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. Male or female patients at the age of 18 to below 75 years with the life
- •expectancy of at least three months.
- •2. Prior confirmed diagnosis of multiple myeloma and measurable disease in
- •blood or urine with at least one of the following: Serum M-protein = 5g/l,
- •Urine M-protein = 200 mg/24 hours, In subjects without detectable serum
- •or urine M-component, serum free light chain (S-FLC) > 100 ml/l
- •(involved light chain) and an abnormal serum kappa/lambda ratio
- •3. Relapse or progression after 1 to 3 prior treatment lines, which have
- •included proteasome inhibitors (PI, bortezomib and/or ixazomib) and/or
- •lenalidomide. Refractoriness to PI´s and/or lenalidomide is allowed in the
- •preceding cycle. Patients must be carfilzomib naíve. Patients with
- •previous autologous transplantation can be included.
- •4. Need of treatment of relapse or progression: IMWG criteria for
- •relapse/progression (paraprotein or CRAB criteria or both). (Appendix 5)
- •5. 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.
- •6. Females of childbearing potential (FCBP) must have a confirmed negative
- •serum pregnancy test within the 7 days prior to inclusion
- •7. Females of childbearing potential must use one effective method of
- •contraception and their partners condom during the study and for 120 days
- •following the last study drug treatment dose and male subjects who are
- •sexually active with FCBP must agree to use condom during the study and
- •for 180 days following the last study drug treatment dose.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2, or
- •Karnofsky at least 60. (Appendix 1)
- •9. Patients must meet the following adequate organ and bone marrow
- •function within 21 days prior to inclusion:
- •Absolute neutrophil count (ANC) 1,000/mm3 (= 1.0 x 109/L) and
- •platelet count 75 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?
- •Hemoglobin (Hb) = 80 g/l (use of erythropoietin and red blood cell
- •transfusions allowed by institutional guidelines, however the most
- •recent RBC may not have given within 7 days prior to obtaining
- •screening Hb
- •Total bilirubin < 1.5 times the upper limit of the normal range (ULN).
- •Alanine aminotransferase (ALT) and aspartate aminotransferase
- •(AST) < 3 times the ULN.
- •Calculated creatinine clearance = 40 mL/min (Cockcroft-Gault
- •estimation of creatinine clearance (CRcl): CRcl (mL/min) = (140 -
- •age) x (weight [kg]) / 72 x (serum creatinine [mg/dL]); for females,
- •multiply by 0.85 (Cockcroft DW. 1976, Luke DR. 1990)(Appendix 2).
- •10. Patient must be willing and able to adhere to the study protocol visit
- •schedule and other protocol requirements.
- •11. Negative pregnancy test at inclusion if applicable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- 另有 4 项未显示
排除标准
- •1. Female patients who are lactating or have a positive serum pregnancy
- •test during the screening period.
- •2. Major surgery within 28 days before enrollment.
- •3. Radiotherapy within 14 days before enrollment, but if the involved field
- •is small, 7 days will be considered a sufficient interval before onset of
- •the treatment.
- •4. Glucocorticoid therapy within the 14 days prior to inclusion that
- •exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg
- •prednisone.
- •5. Central nervous system involvement.
- •6. Infection requiring systemic antibiotic therapy or other serious infection
- •within 14 days before study enrollment.
- •7. Active congestive heart failure (NYHA III-IV) (Appendix 3),
- •symptomatic ischemia, conduction abnormalities uncontrolled by
- •conventional intervention, acute diffuse infiltrative pulmonary disease,
- •pericardial disease or myocardial infarction within 6 months prior to
- •enrollment or left ventricular ejection fraction (LVEF) <40% within one
- •month before randomization.
- •8. Ongoing or active systemic infection, active hepatitis A, B or C virus
- •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. Diagnosed or treated for another malignancy within 5 years before study
- •enrollment or previously diagnosed with another malignancy and have
- •any evidence of residual disease. Patients with nonmelanoma skin
- •cancer or carcinoma in situ of any type are not excluded if they have
- •undergone complete resection.
- •13. Patient has = Grade 3 peripheral neuropathy, or Grade 2 with pain on
- •clinical examination within the 14 days prior to inclusion.
- •14. Participation in another interventional study within the 28 days before
- •this study inclusion.
- •15. Patients that have been previously treated with elotuzumab or
- •carfilzomib.
- •16. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenström
- •macroglobulinemia, rare IgM multiple myeloma, POEMS syndrome,
- •myelodysplasia
- •17. Allogeneic or autologous stem cell transplantation planned
- •18. Participants receiving any other investigational agents or received
- •within 60 days
- •19. Pleural effusions requiring thoracocentesis within the 14 days prior the
- •20. Ascites requiring ascitespunction within the 14 days prior to inclusion.
- •21. Previous allogeneic transplantation
- 另有 4 项未显示
研究者
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