EUCTR2011-002695-16-ES进行中（未招募）1 期
A Phase 2, Randomized Study of Bortezomib/dexamethasone With or Without Elotuzumab in Subjects with Relapsed/Refractory Multiple Myeloma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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) Signed Written Informed Consent
- •a) Subject is, in the investigator?s opinion, willing and able to comply with the protocol requirements.
- •b) Subject has given voluntary written informed consent before performance of any
- •study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- •2) Target Population
- •a) Age >or= 18 years or legal age of consent per local regulations, with a confirmed diagnosis of multiple myeloma and documentation of 1 or 2 prior lines of therapy
- •b) Eastern Cooperative Oncology Group (ECOG) performance status c) Confirmed diagnosis of multiple myeloma with documented progression by IMWG criteria after or during the most recent therapy.
- •d) Measurable disease by IMWG as defined by at least one of the following:
- •i) Serum IgG, IgA or IgM M-protein >or= 0.5 g/dL or IgD M-protein > 0.05 g/dL or
- •ii) Urine M protein >or= 200 mg excreted in a 24-hour collection sample; or
- •iii) Involved serum free light chain level >or= 10 mg/dL provided the free light chain ratio is abnormal
- •3) Age and Reproductive Status
- •a) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for 3 months after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
- •b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the first dose of investigational product.
- •c) Women must not be breastfeeding.
- •d) Sexually active fertile men must use effective birth control if their partners are
- •4) Pharmacogenetic sample
- •To participate in this Pharmacogenetic Sample Amendment, subjects must provide a signed Pharmacogenetic Blood DNA informed consent and must have consented to participate in the main clinical trial CA204009.
- •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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 127
排除标准
- •1) Target Disease Exceptions
- •a) Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
- •b) MGUS, smoldering myeloma or Waldenström?s macroglobulinemia.
- •c) Active plasma cell leukemia.
- •2) Medical History and Concurrent Diseases
- •a) Any medical conditions that, in the investigator?s opinion, would impose excessive risk to the subject. Examples of such conditions include:
- •i) Any uncontrolled disease, such as pulmonary disease, infection, or seizure disorder;
- •ii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
- •b) Significant cardiac disease as determined by the investigator, including:
- •i) Known or suspected cardiac amyloidosis;
- •ii) Congestive heart failure of Class III or IV of the NYHA classification;
- •iii) Uncontrolled angina, hypertension, or arrhythmia;
- •iv) Myocardial infarction in past 6 months;
- •v) Any uncontrolled or severe cardiovascular disease.
- •c) Prior or concurrent malignancy, except for the following:
- •i) Adequately treated basal cell or squamous cell skin cancer;
- •ii) Cervical carcinoma in situ;
- •iii) Adequately treated Stage I or II cancer from which the subject is currently in complete remission;
- •iv) Or any other cancer from which the subject has been disease-free for >or= 3 years.
- •d) Known history of hepatitis B, or documented positive serologies for current
- •(HBsAg positive) or prior hepatitis B infection (anti HBc positive), or hepatitis C
- •or HIV antibodies or infection or active infection with hepatitis A (HAV IgM positive).
- •e) Uncontrolled diabetes (defined as Hgb A1C >or= 8.0% or fasting glucose >or= 160 mg/dL).
- •f) Grade 1 neuropathy with pain or any >or= Grade 2 neuropathy.
- •g) Any residual AEs from prior chemotherapy, surgery, or radiotherapy that have not resolved to < Grade 2.
- •3) Physical and Laboratory Test Findings
- •a) Corrected serum calcium >or= 11.5 mg/dL within 2 weeks of enrollment (despite appropriate measures such as hydration, a short course of steroids, bisphosphonates, or calcitonin).
- •b) Absolute neutrophil count < 1000 cells/mm3. No growth factors allowed within
- •1 week of enrollment.
- •c) Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value.
- •d) Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value.
- •e) Creatinine clearance < 30 mL/minute measured by 24-hour urine collection or
- •estimated by the Cockcroft-Gault formula.
- •f) Total bilirubin > 1.5 x upper limit of normal (ULN).
- •g) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >or= 3 x ULN.
- •4) Prior Therapy or Surgery
- •a) Major surgery within 4 weeks or radiation therapy within 2 weeks prior to randomization
- •b) Thalidomide, lenalidomide, or cytotoxic chemotherapy within 2 weeks of first dose of study drugs
- •c) Prior treatment with any proteasome inhibitor other than bortezomib.
- •d) Steroid use within 3 weeks of randomization, except for equivalent) per day or steroids with little to no systemic absorption (ie, topical or
- •inhaled steroids)
- •e) Treatment with any investigational drug within 3 weeks of randomization
- •f) Prior autolo
研究者
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