NL-OMON50498已完成不适用
An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Daratumumab with the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Subjects with Relapsed or Refractory Multiple Myeloma - PAVO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
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
- •- > /<= 18 years of age
- •- documented secretory multiple myeloma based on International Myeloma Working
- •Group (IMWG) criteria
- •-e vidence of relapsed or refractory disease on the most recent prior treatment
- •- at least 2 prior lines of therapy including a proteasome inhibitor (PI) and
- •an immunomodulatory drug (IMiD);
- •- an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,
排除标准
- •- Prior Daratumumab of other anti-CD38 therapies
- •-Prior Anti- myeloma treatment within 2 weeks before Cycle 1 Day 1
- •- Prior allogenic stem cell transplant
- •- Prior autologous stem cell transplantation (ASCT) within 12 weeks before
- •Cycle 1 Day 1
- •- Participant has a history of malignancy (other than multiple myeloma) within
- •5 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas
- •of the skin and carcinoma in situ of the cervix, or malignancy that in the
- •opinion of the Investigator, with concurrence with the Sponsor's medical
- •monitor, is considered cured with minimal risk of recurrence)
- •Subject is:
- •* known to be seropositive for human immunodeficiency virus (HIV)
- •* seropositive for hepatitis B (defined by a positive test for hepatitis B
- •surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who
- •are HBsAg negative but positive for antibodies to hepatitis B core antigen
- •[Anti HBc] and/or antibodies to hepatitis B surface antigen [Anti HBs]) must be
- •screened using real-time polymerase chain reaction (PCR) measurement of
- •hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be
- •excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV
- •vaccination (Anti HBs positivity as the only serologic marker) AND a known
- •history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- •* known to be seropositive for hepatitis C (except in the setting of a
- •sustained virologic response [SVR], defined as aviremia at least 12 weeks after
- •completion of antiviral therapy).
- •Subject has either of the following:
- •* Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in
- •1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required
- •for subjects suspected of having COPD and subjects must be excluded if FEV1 is
- •<50% of predicted normal.
- •* Known moderate or severe persistent asthma within the past 2 years, or
- •uncontrolled asthma of any classification. Note that subjects who currently
- •have controlled intermittent asthma or controlled mild persistent asthma are
- •allowed to participate in the study.
- •* Subjects with a history of asthma and subjects with a history of COPD who
- •have a FEV1<80% at screening are excluded from the *3+3* portions of the
- •corticosteroid tapering cohorts in Part 3.
- •Clinically significant cardiac disease, including:
- •* myocardial infarction within 6 months before Cycle 1 Day 1, or an unstable or
- •uncontrolled disease/condition related to or affecting cardiac function (eg,
- •unstable angina, congestive heart failure, New York Heart Association Class
- •* uncontrolled cardiac arrhythmia (NCI-CTCAE [Version 4.03] Grade 2 or higher)
- •or clinically significant electrocardiogram (ECG) abnormalities; or
- •* screening 12-lead ECG showing a baseline QT interval as corrected (QTc) >470
研究者
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