EUCTR2013-002101-62-GB进行中（未招募）1 期
Pomalidomide in relapsed and refractory multiple myeloma (RRMM) - MUK Seven
niversity of Leeds0 个研究点目标入组 250 人开始时间: 2014年11月26日最近更新:
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
- 250
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
- •Diagnosed with symptomatic multiple myeloma (according to IMWG 2014 criteria) and have measurable disease
- •Participants must require therapy for relapsed and/or refractory disease
- •Participants must have received = 2 treatment lines of anti-myeloma therapy (induction therapy followed by ASCT and consolidation/maintenance will be considered as one line).
- •Participants must have received prior treatment with both lenalidomide and a proteasome inhibitor, either as single agents or in combination regimens
- •All participants must have failed treatment with either lenalidomide and a proteasome inhibitor in one of the following ways:
- •1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or a proteasome inhibitor; or
- •2) In case of prior response [= partial response (PR)] to lenalidomide or a proteasome inhibitor, participants must have relapsed within 6 months after stopping treatment with lenalidomide and/or a proteasome inhibitor-containing regimens; or
- •3) Participants who have not had a = minimal response (MR) despite receiving at least 4 cycles of treatment or who have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or a proteasome inhibitor-containing regimen
- •Patients must have received adequate prior alkylator therapy in one of the following ways
- •a.As part of a stem cell transplant; or
- •b.A minimum of 4 consecutive cycles of an alkylator based therapy; or
- •c.Progression on treatment with an alkylator; provided that the participant received at least 2 cycles of an alkylator-containing therapy.
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •Required laboratory values within 14 days of day 1 of treatment:
- •oAbsolute neutrophil count = 1.0 x109 /L (growth factor support is permitted)
- •oPlatelet count = 30 x 109/L (platelet transfusion is permitted)
- •oCreatinine clearance > 30 mL/min (using Cockcroft Gault formula)
- •oCorrected serum calcium = 3.5 mmol/L
- •oHaemoglobin = 8 g/dL (blood transfusion support is permitted)
- •oAspartate aminotransferase (AST) or Alanine aminotransferase (ALT) < 3 times Upper Limit of Normal (ULN)
- •oSerum total bilirubin < 17µmol/l
- •Participants must consent to provide the bone marrow samples specified at screening and throughout the trial, in order to enter the trial. Confirmation of receipt of the sample from the lab must be received before treatment commences.
- •Able to give informed consent and willing to follow trial protocol
- •Aged over 18 or over
- •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.
- •Females must agree to abstain from breastfeeding during trial participation and 28 days after trial drug discontinuation
- •Males must agree to use a latex condom during any sexual contact with FCBP during the trial, including during any 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 pomalidomide, including during any dose interruptions and for 28 days after discontinuation from this tria
排除标准
- •Previous therapy with pomalidomide
- •Hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone
- •Participants with non-secretory multiple myeloma
- •Peripheral neuropathy = Grade 3
- •Participants who have received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
- •Previous anti-tumour therapies including investigational medicinal products at any dose within 28 days before the start of protocol treatment (or 5 half-lives, whichever is longer). A pulse of dexamethasone may be given up to 14 days before the start of protocol treatment Bisphosphonates for bone disease and radiotherapy for palliative intent are permitted.
- •Participants with any of the following
- •a.Uncontrolled congestive heart failure
- •b.Myocardial infarction within 12 months prior to starting trial treatment
- •c. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
- •Participants with gastrointestinal disease that may significantly alter absorption of pomalidomide
- •Participants with a history of other malignancies within 5 years before the date of study entry (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that is considered cured with minimal risk of recurrence within 5 years).
- •Participants unable or unwilling to undergo antithrombotic prophylactic treatment
- •Pregnant or breastfeeding females
- •Participants known to be seropositive for HIV, or active infectious hepatitis A, B or C
- •Participants for any reason unwilling or cannot consent to follow the Pomalidomide pregnancy prevention programme
- •Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if they were to participate in the trial
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