EUCTR2014-005325-12-GR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
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
- •1. Age = 18 years
- •2. Able to provide written informed consent in accordance with federal, local, and institutional
- •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:
- •[(140 – Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female
- •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
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
- •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
- •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, 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 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
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