NCT06976476招募中2 期
Prospective Randomized Phase II Study Evaluating Efficacy and Safety of IgPro20 as Infection Prophylaxis in Patients With Multiple Myeloma and Hypogammaglobulinemia Receiving Therapy With a Bispecific Monoclonal Antibody (BsAbs)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20
研究概览
简要总结
The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RRMM receiving a commercially available bispecific antibody
- •Received at least 1 but no more than 4 cycles of BsAb
- •Males or females greater than or equal to 18 years old at the time of consent
- •Life expectancy > 12 months
排除标准
- •HSCT within 3 months before enrollment
- •Planned CAR-T therapy in the next 6 months
- •>1 major (deep-seated) infection within the preceding 3 months
- •HIV infection, Active HCV, or Active HBV infection
- •Pregnancy
- •Neutrophils < 500 x 10^3 per mL, Platelets < 30 x 10^9 per mL
- •History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation
- •Known reaction/allergy to IgG products
- •Intracranial hemorrhage or embolic CVA in the last 6 months
- •Hyperproteinemia
- •Protein-losing enteropathy
- •Creatinine Cl <30 ml/min
- •Documented progression on BsAb
- •Known history of Hyperprolinemia
- •On current or previous IVIG (in the last 3 months)
研究组 & 干预措施
Standard of Care + IGRT prophylaxis with IgPro20
Experimental
Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care
干预措施: IgPro20 (Drug)
Standard of Care
No Intervention
Participants will only be observed
结局指标
主要结局
Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20
时间窗: 6 months
To compare overall infection rates amongst (RR) multiple myeloma patients with hypogammaglobulinemia receiving subcutaneous immunoglobulin (IgPro20) to those in observational arm over a 6-month period.
次要结局
未报告次要终点
研究者
研究点 (16)
Loading locations...
相似试验
已完成
4 期
A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in AdultsCovid19 VaccineNCT05079633National Taiwan University Hospital220
已完成
2 期
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy AdultsChikungunya Virus InfectionNCT03483961Bavarian Nordic445
已完成
2 期
Phase II Trial Designed to Determine Efficacy and Safety of Bendamustine+Dexamethasone+Thalidomide in R/R MMMultiple MyelomaNCT01526694Azienda Ospedaliera di Bolzano30
已完成
1 期
A Safety and Pharmacokinetics Study in Participants With Rheumatoid ArthritisArthritis, RheumatoidNCT00380744Eli Lilly and Company121
撤回
2 期
A Phase II Study of H56:IC31 in Healthy AdolescentsTuberculosis InfectionNCT03265977Aeras