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临床试验/NL-OMON48807
NL-OMON48807招募中2 期

A Phase 2, Open-Label Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM) - C16047

Takeda0 个研究点目标入组 1 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
1
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •Each patient must meet all of the following inclusion criteria to be enrolled
  • •in the study:
  • •Adult patients (aged >=18 years) who have been diagnosed with MM according to
  • •IMWG criteria.
  • •All patients must have measurable disease by at least 1 of the following
  • •measurements:
  • •- Serum M-protein >=1 g/dL (>=10 g/L).
  • •- Urine M-protein >=200 mg/24 hours.
  • •All patients must have documented evidence of PD on or after their last
  • •regimen as defined by IMWG criteria (see Appendix E) [1-3]. All patients must
  • •have received between 1 to 3 prior therapies for MM (a prior therapy is defined
  • •as 2 or more cycles of therapy given as a treatment plan for MM [eg, a
  • •single-agent or combination therapy or a sequence of planned treatments such as
  • •induction therapy followed by autologous SCT and then consolidation and/or
  • •maintenance therapy]).
  • •All patients must have achieved a response (PR or better) to at least 1 prior
  • •All patients must have an Eastern Cooperative Oncology Group (ECOG) score of
  • •0, 1, or 2.
  • •All patients must meet the following laboratory criteria:
  • •- Absolute neutrophil count (ANC) >=1000/mm3.
  • •- Platelet count >=75,000/mm3.
  • •- Total bilirubin <=1.5 x the upper limit of the normal range (ULN) (except for
  • •Gilbert syndrome: direct bilirubin <=2 x ULN).
  • •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 x ULN.
  • •- Calculated creatinine clearance >=50 mL/min.
  • •Female patients who:
  • •- Are postmenopausal for at least 1 year before the screening visit, OR
  • •- Are surgically sterile, OR
  • •- If they are of childbearing potential, agree to use effective contraceptive
  • •measures during and for 90 days following treatment. Advise women using
  • •hormonal contraceptives to also use a barrier method of contraception (see
  • •Appendix H for details).
  • •Male patients, even if surgically sterilized (ie, status postvasectomy), who:
  • •- Agree to use effective contraceptive measures during and for 90 days
  • •following treatment (see Appendix H for details).
  • •Voluntary written consent must be given before performance of any
  • •study-related procedure not part of standard medical care, with the
  • •understanding that consent may be withdrawn by the patient at any time without
  • •prejudice to future medical care.
  • •Patient is willing and able to adhere to the study visit schedule and other
  • •protocol requirements.

排除标准

  • •Patients meeting any of the following exclusion criteria are not to be enrolled
  • •in the study:
  • •Patients have undergone prior allogenic bone marrow transplantation.
  • •Patients have received prior ixazomib at any time or daratumumab or other
  • •anti-CD38 therapies, except as part of initial therapy if this was stopped to
  • •move on to SCT and the patient did not progress on anti-CD38 treatment.
  • •Patients are refractory to bortezomib or carfilzomib at the last exposure
  • •before this study (defined as patient having PD while receiving bortezomib or
  • •carfilzomib therapy or within 60 days after ending bortezomib or carfilzomib
  • •Patients planning to undergo SCT prior to PD on this study (ie, these
  • •patients should not be enrolled in order to reduce disease burden prior to
  • •transplant).
  • •Patients receiving systemic treatment with strong CYP3A inducers (rifampin,
  • •rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John's
  • •wort) within 14 days before randomization.
  • •Patient has received autologous SCT within 12 weeks before the date of study
  • •Patient has received an investigational drug (including investigational
  • •vaccines) within 4 weeks before study treatment (except for investigational
  • •antimyeloma agents, which cannot be taken within 2 weeks prior or 5 PK
  • •half-lives of the treatment, whichever is longer, before the date of study
  • •treatment). The only exception is emergency use of a short course of
  • •corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum 4 days)
  • •before treatment.
  • •Patients with known chronic obstructive pulmonary disease (COPD) with a
  • •forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note:
  • •FEV1 testing is required for subjects suspected of having COPD and subjects
  • •must be excluded if FEV1 is <50% of predicted normal.
  • •- Patients with Grade 2 or higher residual toxicities from prior therapy
  • •(including Grade 2 or higher peripheral neuropathy or any grade neuropathy with
  • •pain; excluding alopecia). This includes recovery from any major surgery. Note:
  • •Subjects with planned surgical procedures to be conducted under local
  • •anesthesia may participate. Kyphoplasty or vertebroplasty are not considered
  • •major surgery.
  • •Patients with known allergy to any of the study medications, their analogues,
  • •their excipients, mAbs or human proteins or known sensitivity to
  • •mammalian-derived products.
  • •Patient has uncontrolled clinically significant cardiac disease, including
  • •myocardial infarction within 6 months before date of study entry or unstable or
  • •uncontrolled angina, congestive heart failure, New York Heart Association
  • •(NYHA) Class III-IV, uncontrolled cardiac arrhythmia (Grade 2 or higher).
  • •Patients with ongoing or active systemic infection requiring IV medical
  • •management; patients with known HIV-RNA positivity; patients with hepatitis B
  • •virus (HBV) surface antigen or core antibody positivity,; and patients with
  • •known hepatitis C virus-RNA positivity. Patients who have positive hepatitis C
  • •antibody can be enrolled but must have hepatitis C virus-RNA negativity.
  • •Patient has any concurrent medical condition or disease that is likely to
  • •interfere with study procedures, results, or assessment of safety or toxicity
  • •or that in the opinion of the investigator would constitute a hazard for
  • •participati

研究者

发起方
Takeda

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