ACTRN12618001490268进行中（未招募）2 期
MM21 - A multicenter, single arm, study of daratumumab-lenalidomide-dexamethasone (DRd) for newly diagnosed transplant eligible multiple myeloma patients who fail bortezomib-based induction therapy.
Australiasian Leukaemia and Lymphoma Group0 个研究点目标入组 50 人开始时间: 2018年9月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Male and Female patients, greater than or equal to 18 years of age.
- •2.Symptomatic NDMM as per IMWG criteria
- •3.Eligible for high-dose melphalan conditioned ASCT.
- •4.Patients who have had a sub-optimal response to a bortezomib-based induction therapy, where a sub-optimal response is defined as:
- •The failure to achieve at least a minimal response (MR) with a minimum of 2 cycles of a prior bortezomib-based induction therapy OR a partial response (PR) with 4 cycles of a prior bortezomib-based induction therapy
- •OR are bortezomib refractory, that is, have progressed while on bortezomib therapy or within 60 days of receiving their last dose of bortezomib.
- •5.No contraindication to the use of any of the study drugs.
- •6.Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.
- •7.Absolute neutrophil count greater than or equal to 1.0 x 109/L.
- •8.Platelet count greater than or equal to 50 x 109/L (greater than or equal to 30 x 109/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
- •9.Hb greater than or equal to 80g/L, red cell transfusions as per institutional protocol are allowed.
排除标准
- •1.Patients who have had myocardial infarction within 6 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •2.Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.
- •3.Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency (HIV) positivity.
- •4.Subject has significant airways disease according to the following definitions:
- •a.Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal.
- •b.Subject has had known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
- •5.Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
- •6.Any patient who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention program.
- •7.Active malignancy with the exception of any of the following:
- •a.Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
- •b.Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for greater than 2 years.
- •c.Stage 1 prostate cancer that does not require treatment.
- •d.Any other cancer from which the subject has been disease-free for greater than 2 years.
- •8.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
- •9.Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
研究者
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