2024-518420-80-00招募中3 期
A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation Antigen×CD3–Directed Bispecific Antibody Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 143
- 试验地点
- 35
- 主要终点
- Time to the first serious infection.
研究概览
简要总结
To assess the efficacy of IGI, 10% treatment for primary infection prophylaxis compared with secondary infection prophylaxis.
研究设计
- 分配方式
- Randomized
- 主要目的
- Igi 10% For Primary Prophylaxis Vs Secondary Prophylaxis In Mm Subjects On Bcmax Cd3 Bs Ab Therapy
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The subject must have a documented diagnosis of MM according to the guidelines by the IMWG before enrollment.
- •Subjects who recently started teclistamab within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
- •The subject or the subject’s legally acceptable representative has provided informed consent (ie, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures.
- •The subject is at least 18 years of age at the time of signing the ICF.
- •If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug: • To use a highly effective contraceptive method. • To avoid donating ova.
排除标准
- •The subject has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
- •The subject is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
- •The subject may be excluded from the study if, in the opinion of the investigator, the subject is at high risk for symptomatic hyperviscosity syndrome.
- •The subject has major surgery scheduled during the study, or the subject has not fully recovered from a recent major surgery (as judged by the investigator) during screening (subjects with planned surgical procedures to be conducted under local anesthesia may participate).
- •The subject has an active secondary (non-MM) malignancy or other medical condition with life‑expectancy of <2 years.
- •The subject has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after IVIG and/or immune serum globulin infusions.
- •The subject has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening.
- •The subject has moderate to severe renal dysfunction based on an estimated glomerular filtration rate ≤30 mL/min/1.73 m2, as defined by Kidney Disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening.
- •The subject has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, PCR for hepatitis C virus, PCR for HIV Type 1 and Type
- •Cured subjects with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
- •The subject has a documented diagnosis of a form of PID involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee.
- •The subject has a persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal at screening (may be repeated once to determine if it is persistent).
- •The subject has a current serious infection or >1 serious infection in the past 3 months before screening.
- •The subject has an immunoglobulin A (IgA) deficiency (<0.07 g/L) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.
- •Subjects with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator’s brochure/package insert/Summary of Product Characteristics.
- •Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
- •The subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).
- •The subject has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the subject at undue medical risk.
- •The subject is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
- •The subject or the subject’s legally designated representative is not willing and able to comply with the protocol requirements.
- •The subject has participated or is scheduled to participate in another clinical study involving an IP or investigational device within 30 days before screening and during the course of the study.
- •The subject is a family member or employee of the investigator or the investigator’s site staff.
- •The subject is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.
- •The subject has a documented polyclonal IgG level <150 mg/dL at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site’s standard practice.
- •The subject is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
- •The subject has received a hyperimmune or specialty high-titer immunoglobulin product (eg, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.
- •The subject has received live viral vaccines within 30 days before screening.
- •The subject has an Eastern Cooperative Oncology Group performance status score of >
- •The subject has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.
- •The subject has received other BCMA×CD3–directed BsAb therapy any time before screening.
结局指标
主要结局
Time to the first serious infection.
Time to the first serious infection.
次要结局
- 1. Occurrence of at least 1 serious infection during the observational period of 12 months.
- 2. Annualized rate of days on antibiotics (for treatment of bacterial infections).
- 3. Annualized rate of bacterial infections.
研究者
Filiz Seeborg
Scientific
Takeda Development Center Americas Inc.
研究点 (35)
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