EUCTR2014-005325-12-DE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
- 460
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
- •101. Age = 18 years
- •102. Able to provide written informed consent in accordance with federal, local,
- •and institutional guidelines
- •103. Relapsed multiple myeloma
- •104. Refractory multiple myeloma, defined as meeting 1 or more of the following:
- •a. Nonresponsive to most recent therapy (stable disease or progressive disease [PD] while on treatment), or
- •b. Disease progression within 60 days of discontinuation from most recent therapy
- •105. At least 2, but no more than 3, prior lines of therapy for multiple myeloma
- •106. Prior exposure to an IMiD
- •107. Prior exposure to a proteasome inhibitor (PI)
- •108. Documented response of at least partial response (PR) to at least 1 prior line of therapy
- •109. Measurable disease, with at least 1 of the following assessed at a central laboratory 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 measurable serum or urine M-protein, serum free light chain (SFLC) = 100 mg/L (involved light chain) and an abnormal serum kappa:lambda ratio
- •110. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •111. Left ventricular ejection fraction (LVEF) = 40% within the 21 days prior to randomization
- •112. Adequate organ and bone marrow function performed at a central laboratory
- •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) = 1 × 109/L (screening ANC must be independent of growth factor support for = 7 days)
- •d. Hemoglobin = 8 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusions per institutional guidelines are allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining the screening hemoglobin.)
- •e. Platelet count = 50,000/mm3 (= 30,000/mm3 if myeloma involvement in the
- •bone marrow is > 50%. Subjects must not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count.)
- •f. Calculated or measured creatinine clearance (CrCl) of = 30 mL/min. Calculation must be based on the Cockcroft and Gault formula: [(140 – Age) × Mass (kg) / (72 × Creatinine mg/dL)]; multiply result by 0.85 if female
- •113. Females of childbearing potential (FCBP) must have a confirmed negative serum
- •pregnancy test performed at a central laboratory, within the 21 days prior to
- •randomization, and must not be breastfeeding.
- •114. Females of childbearing potential must agree to use highly effective method(s) of
- •contraception, during the study and for 30 days following the last study drug
- •administration (Refer to Appendix K for specific contraceptive requirements).
- •115. Male subjects who are sexually active with an FCBP must agree to use condoms (unless they have had a vasectomy with medical confirmation of surg
排除标准
- •201. Waldenström macroglobulinemia
- •202. Multiple myeloma of Immunoglobulin M (IgM) subtype
- •203. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal
- •protein, and skin changes)
- •204. Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard
- •differential)
- •205. Myelodysplastic syndrome
- •206. 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
- •207. History of or current amyloidosis
- •208. Cytotoxic chemotherapy or other antineoplastic therapy, aside from
- •immunotherapy or proteasome inhibitors, within the 28 days prior to randomization
- •209. Immunotherapy, such as an IMiD, or a proteasome inhibitor, within the 21 days prior to randomization
- •210. Glucocorticoid therapy exceeding a cumulative dose of 160 mg dexamethasone or
- •equivalent, within the 14 days prior to randomization
- •211. Radiation therapy:
- •a. Focal therapy within the 7 days prior to randomization
- •b. Extended field therapy within the 21 days prior to randomization
- •212. Prior treatment with either carfilzomib or oprozomib
- •213. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize
- •carfilzomib)
- •214. Contraindication to dexamethasone or any of the required concomitant medications or supportive treatments
- •215. Active congestive heart failure (New York Heart Association [NYHA] Class III or IV, refer to Appendix F), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to randomization
- •216. Active infection requiring systemic treatment within the 14 days prior to
- •randomization
- •217. Pleural effusions requiring thoracentesis within the 14 days prior to randomization
- •218. Ascites requiring paracentesis within the 14 days prior to randomization
- •219. Ongoing graft-versus-host disease
- •220. Uncontrolled hypertension or diabetes mellitus
- •221. Significant neuropathy (= Grade 3) within the 14 days prior to randomization
- •222. Known cirrhosis
- •223. Known human immunodeficiency virus (HIV) seropositivity, hepatitis C infection, or hepatitis B infection. Subjects with past hepatitis B virus 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
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