EUCTR2016-002438-58-ES进行中（未招募）1 期
A phase 1b/2 trial to evaluate the safety and efficacy of radium-223 dichloride (BAY 88-8223) in combination with bortezomib and dexamethasone in early relapsed multiple myeloma - Phase 1b/2 study testing radium-223 dichloride in relapsed multiple myeloma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 226
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
- •Subjects must meet the following criteria for inclusion in the study (applicable to both parts of the study):
- •1. Males or females =18 years of age
- •2. Have provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent, expressing their willingness and ability tocomply with protocol-required treatment and assessment schedule, including follow-up visits. A signed ICF must be appropriately obtained prior to the conduct of any trial-specific procedure.
- •3. Subject must have documented monoclonal plasma cells as defined by their institutional standard in the bone marrow >=10% at some point in their disease history or presence of a biopsy proven plasmacytoma
- •4. Subjects must have received at least 1 and not more than 3 previous lines of treatment and have had a response to treatment (i.e., achieved a minimal response [MR] or better) according to the IMWG uniform response criteria; see Definition of terms section for description of lines of therapy
- •5. Subject must be non-refractory to bortezomib or another PI, like ixazomib and carfilzomib (Refractory is defined: progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another PI therapy, like ixazomib and carfilzomib)
- •6. Subjects must have had progressive disease according to the IMWG uniform response criteria following the last multiple myeloma treatment
- •7. Subjects must have measurable disease defined as at least 1 of the following (according to central laboratory results):
- •- Serum M-protein defined by the following:
- •* IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL
- •* IgA, IgD, IgE, IgM multiple myeloma: serum M-protein level =0.5 g/dL
- •- Urine M-protein =200 mg/24 hours (any immunoglobulin heavy chain type)
- •- Serum free light chain (FLC) =10 mg/dL with abnormal ratio
- •8. =1 bone lesion identifiable by radiograph, computed tomography, PET-CT, or MRI
- •9. Life expectancy of at least 3 months
- •10. Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2
- •11. Adequate hepatic function, with bilirubin =1.5 x ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3.0 x ULN
- •12. Absolute neutrophil count (ANC) =1.5 × 10E9/L, hemoglobin (Hb) =9.0 g/dL, and platelet count =75.0 × 109/L independent of transfusion of red blood cells (RBC) or platelet concentrates and independent of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
- •13. International normalized ratio (INR) = 1.5 and partial thromboplastin time (PTT) = 1.5 x ULN. PT can be used instead of INR if = 1.5 x ULN
- •14. Calculated or measured creatinine clearance of =30 mL/minute, calculated using the formula of Cockcroft and Gault [(140 - age) x mass (kg)/(72 x creatinine mg/dL)]. Multiply result by 0.85 if female
- •15. Female subjects of child-bearing potential must have a negative serum pregnancy test within 72 hours before the first dose. Post-menopausal females (age =55 years and 1 year or more of amenorrhea; OR age <55 years and 1 year or more of amenorrhea with an estradiol assay <20 pg/mL; OR bilateral oophorectomy) and surgically sterilized females are exempt from a pregnancy test.
- •16. a) Female subjects of child-bearing potential who are sexually active must agree to utilize, during treatment with and for 6 months after the last dose of radium-223 dichloride/placebo/ bortezomib/dexamethasone, 2 reliable and accep
排除标准
- •Subjects must not meet any of the exclusion criteria listed below (applicable to both parts of the study):
- •1. Systemic glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 4 weeks prior to first dose, unless tapered and on a stable dose (prednisone =10 mg/day orally or equivalent) for at least 1 week
- •2. Subjects with known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or light-chain (AL) amyloidosis
- •3. Plasma cell leukemia (defined by plasma cell >20%, and/or an absolute plasma cell count of >2 x 10E9/L in peripheral blood)
- •4. Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM)
- •5. Radiation therapy in the previous 4 weeks prior to first dose except if given for pain management and involves less than 10% of the bone marrow
- •6. Administration of an investigational therapeutic study drug within 4 weeks or within 5 drug half-lives (t1/2), whichever time is greater, prior to first dose
- •7. Prior treatment with radium-223 dichloride or any experimental radiopharmaceutical
- •8. Major surgery within 4 weeks prior to first dose (central line placement is not considered a major surgery)
- •9. Congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic cardiac ischemia, cardiomyopathy, clinically relevant ventricular arrhythmia, pericardial disease, unstable angina or myocardial infarct in the previous 6 months prior to first dose, left ventricular ejection fraction <40%
- •10. Acute diffuse infiltrative pulmonary disease
- •11. Acute active infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose
- •12. Known HIV infection or subjects who are known to be HIV seropositive
- •13. Subject with active hepatitis B or C infection at screening; subjects with known history of occult or hepatitis B virus (HBV) infection (defined as positive hepatitis B core antibody [HBcAb] and negative hepatitis B surface antigen [HBsAg]), but have undetectable HBV DNA at screening may be included. Subjects with history of positive for hepatitis C virus (HCV) antibody must be negative for HCV RNA by polymerase chain reaction (PCR) assessment or similar technology to be included.
- •14. Any history of malignancy within the past 3 years except adequately treated a) basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, c) prostate carcinoma in situ < Gleason Score 6 with stable PSA, or d) breast carcinoma in situ
- •15. Neuropathy = Grade 2 or Grade 1 with pain
- •16. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
- •17. Hypersensitivity to radium-223 dichloride, bortezomib, or dexamethasone or their excipients
- •18. Any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
- •19. Female subjects who are pregnant or lactating
- •20. Serious psychiatric condition that could interfere with compliance of treatment
- •21. Close affiliation with the investigational site (e.g., a close relative of the Investigator, dependent person [e.g., employee or student of the investigational site])
研究者
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