EUCTR2016-002670-12-GB进行中（未招募）1 期
MUK nine b: OPTIMUM. A phase II study evaluating multiple novel agentsoptimised combination of biological therapy in newly diagnosed high risk multiple myeloma and plasma cell leukaemia. - MUK Nine b: Optimum
niveristy of Leeds0 个研究点目标入组 95 人开始时间: 2017年2月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
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
- •Target participants:
- •Confirmation of High Risk status from ICR following bone marrow and blood sample processed through the screening protocol. Participants with confirmed plasma cell leukaemia with >20% circulating plasma cells, do not need confirmation of High Risk status from ICR to proceed on MUKnine b.
- •Confirmation of receipt by CTRU of baseline bone marrow, at HMDS and blood and urine samples at University of Birmingham at MUKnine a baseline.
- •Previously untreated participants, although participants may have received up to 2 cycles of CTD (Cyclophosphamide, thalidomide, dexamethasone), CVD (Cyclophosphamide, velcade, dexamethasone), CRD (cyclophosphamide, revlamid, dexamethasone) or VTD (velcade, thalidomide, dexamethasone) pre-trial induction chemotherapy while awaiting the results of the laboratory analysis from the MUK nine a Protocol.(In addition, non-systemic therapy such as therapeutic plasma exchange, dexamethasone up to a maximum of 160mg or radiotherapy sufficient to alleviate or control pain or local invasion is permitted).
- •Measurable disease with at least one of the following or willing to undergo further bone marrows for assessment:
- •- Paraprotein = 5g/L or = 0.5 g/L for IgD subtypes.
- •- Serum free kappa or lambda light chains = 100 mg/L with abnormal ratio (for light chain only myeloma).
- •- Urinary Bence Jones protein = 200 mg/L.
- •Non measurable participants providing they accept a 3 monthly bone marrow during induction and a 6 monthly bone marrow assessment during consolidation and maintenance.
- •Aged 18 years or over.
- •Fit for intensive chemotherapy and autologous stem cell transplant (at clinician’s discretion).
- •ECOG Performance Status (Eastern Cooperative Oncology Group) =2.
- •The Celgene Pregnancy Prevention Plan must be followed and participants must agree to comply with this:
- •Females of childbearing potential (FCBP) must agree to utilise two reliable forms of contraception simultaneously or practice complete abstinence for at least for 28 days prior to starting trial treatment, during the trial and for at least 28 days after trial treatment discontinuation, and even in case of dose interruption, and must agree to regular pregnancy testing during this timeframe.
- •Males must agree to use a latex condom during any sexual contact with FCBP during the trial, including during dose interruptions and for 28 days following discontinuation from this trial even if he has undergone a successful vasectomy
- •Males must also agree to refrain from donating semen or sperm while on trial treatment including during any dose interruptions and for 4 months after discontinuation from this trial
- •All participants must agree to refrain from donating blood while on trial drug including during dose interruptions and for 28 days after discontinuation from this trial.
- •- Calculated creatinine clearance = 30mL/min (using Cockcroft-Gault formula).
- •- ALT and/or AST = 2.5 times upper limit of normal (ULN).
- •- Bilirubin = 2.0 x ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin =2.0 times ULN
- •- Platelet count = 75 x 109/L. (= 50 x 109/L if myeloma involvement in the bone marrow is >50%). Platelet support is permitted.
- •- Absolute neutrophil count (ANC) = 1.0 x 109/L. Growth factor support is permitted.
- •- Haemoglobin = 80 g/L. (Participants may be receiving red blood cell (RBC) transfusions in accordance with institutional guidelines.
- •- Corrected serum calcium = 3.5 mmol/L.
排除标准
- •Exclusion Criteria
- •Participants that have progressive disease
- •Solitary bone/solitary extramedullary plasmacytoma.
- •Primary diagnosis of amyloidosis, monoclonal gammopathy of undetermined significance or smoldering multiple myeloma or Waldenstrom’s Disease.
- •Medical history and Concurrent disease:
- •Prior or concurrent invasive malignancies except the following:
- •oAdequately treated basal cell or squamous cell skin cancer.
- •oIncidental finding of low grade (Gleason 3+3 or less) prostate cancer.
- •oAny cancer from which the subject has been disease free for at least 3 years.
- •Known/underlying medical conditions that, in the investigator’s opinion, would make the administration of the study drug hazardous (e.g uncontrolled diabetes or uncontrolled coronary artery disease).
- •oAny clinically significant cardiac disease, including:
- •omyocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV.
- •ouncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4 Grade =2) or clinically significant ECG (Electrocardiogram) abnormalities.
- •oscreening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) >470 msec.
- •Known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume [FEV] in 1 second <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed). Participants with known or suspected COPD or asthma must have a FEV1 test during screening.
- •Known to be seropositive for history of human immunodeficiency virus (HIV) or known to have active hepatitis B or hepatitis C.
- •Any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products.
- •Clinically significant allergies or intolerance to cyclophosphamide, lenalidomide, velcade, daratumumab or dexamethasone.
- •Previous treatment with daratumumab or any other anti-CD38 therapies.
- •Participants with contraindication to thromboprophylaxis.
- •Grade 2 or greater peripheral neuropathy (per NCI-CTCAEv4.0).
- •Participants with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
- •Known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this trial, 4 months after the last dose of trial treatment. Or, participant is a man who plans to fathe
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