EUCTR2014-005325-12-GB进行中（未招募）1 期
A Randomized, Open-label, Phase 3 Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination with Dexamethasone, Comparing Once-weekly versus Twice-weekly Carfilzomib Dosing - A.R.R.O.W.
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
- 415
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. Age = 18 years
- •2. Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- •3. Relapsed multiple myeloma
- •4. Refractory multiple myeloma defined as meeting 1 or more of the following:
- •a. Nonresponsive to most recent therapy (stable disease only or PD while on treatment), or
- •b. Disease progression within 60 days of discontinuation from most recent therapy
- •5. At least 2 but no more than 3 prior therapies for multiple myeloma
- •6. Prior exposure to an immunomodulatory agent (IMiD)
- •7. Prior exposure to a proteasome inhibitor (PI)
- •8. Documented response of at least partial response (PR) to 1 line of prior therapy
- •9. Measurable disease with at least 1 of the following assessed within the 21 days prior to randomization:
- •a. Serum M-protein = 0.5 g/dL
- •b. Urine M-protein = 200 mg/24 hours
- •c. In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) = 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
- •10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •11. Left ventricular ejection fraction (LVEF) = 40% within the 21 days prior to randomization
- •12. Adequate organ and bone marrow function within the 21 days prior to randomization defined by:
- •a. Bilirubin < 1.5 times the upper limit of normal (ULN)
- •b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
- •c. Absolute neutrophil count (ANC) = 1000/mm3 (screening ANC should be independent of growth factor support for = 1 week)
- •d. Hemoglobin = 8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
- •e. Platelet count = 50,000/mm3 (= 30,000/mm3 if myeloma involvement in the bone marrow is > 50%. Subjects should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count).
- •f. Calculated or measured creatinine clearance (CrCl) of = 30 mL/min
- •Calculation should be based on the Cockcroft and Gault formula.
- •13. Females of childbearing potential (FCBP) must have a confirmed negative serum pregnancy test within the 21 days prior to randomization (performed at a central laboratory).
- •14. Females of childbearing potential and male subjects who are sexually active with FCBP must agree to use effective concomitant method(s) of contraception during the study and for 30 days following the last study drug treatment administration.
- •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 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. Waldenström macroglobulinemia
- •2. Multiple myeloma of Immunoglobin M (IgM) subtype
- •3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •4. Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
- •5. Myelodysplastic syndrome
- •6. Second malignancy within the past 5 years except:
- •a. Adequately treated basal cell or squamous cell skin cancer
- •b. Carcinoma in situ of the cervix
- •c. Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
- •d. Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
- •e. Treated medullary or papillary thyroid cancer
- •f. Similar condition with an expectation of >95% five-year disease-free survival
- •7. History of or current amyloidosis
- •8. Cytotoxic chemotherapy within the 28 days prior to randomization
- •9. Immunotherapy within the 21 days prior to randomization
- •10. Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone
- •11. Radiation therapy:
- •a. Focal therapy within the 7 days prior to randomization
- •b. Extended field therapy within the 21 days prior to randomization
- •12. Prior treatment with either carfilzomib or oprozomib
- •13. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
- •14. 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
- •15. Active congestive heart failure(New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to enrollment
- •16. Active infection within the 14 days prior to randomization requiring systemic antibiotics
- •17. Pleural effusions requiring thoracentesis within the 14 days prior to randomization
- •18. Ascites requiring paracentesis within the 14 days prior to randomization
- •19. Ongoing graft-versus-host disease
- •20. Uncontrolled hypertension or uncontrolled diabetes despite medication
- •21. Significant neuropathy (= Grade 3) within the 14 days prior to randomization
- •22. Known cirrhosis
- •23. Known human immunodeficiency virus (HIV) seropositivity, hepatitis C infection, or hepatitis B infection (subjects with past hepatitis B virus (HBV) infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.)
- •24. Participation in another interventional study within the 28 days prior to randomization
- •25. Major surgery (except kyphoplasty) within the 28 days prior to randomization
- •26. Female subjects who are pregnant or lactating
- •27. Any other clinically significant medical disease or social condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent, be compliant with study procedures, or provide accurate information.
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