The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- Determine the real-world overall response rates (ORR)
研究概览
简要总结
The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants age ≥ 18 years
- •Prior diagnosis of one of the following
- •Multiple myeloma as defined according to IMWG criteria
- •Primary plasma cell leukemia as defined according to IMWG consensus definition
- •AL-amyloidosis as defined according to IMWG criteria
- •Planned treatment with one of the following outside clinical trials (list to be amended based on approvals within the EU):
- •Teclistamab (Tecvayli)
- •Elranatamab (Elrexfio)
- •Talquetamab (Talvey)
- •Idecabtagene vicleucel (ide-cel/Abecma)
- •Ciltacabtagene autoleucel (cilta-cel/Carvykti)
排除标准
- 未提供
结局指标
主要结局
Determine the real-world overall response rates (ORR)
时间窗: From date of treatment start and until date of first documented progression or start of next line of therapy, whichever came first, assessed up to ten years.
Determine real-world progression-free survival (PFS)
时间窗: From date of treatment start and until date of first documented progression or death, whichever came first, , assessed up to ten years.
Determine real-world time-to-next treatment (TTNT)
时间窗: From date of treatment start and until date of start of next treatment, assessed up to ten years.
Determine real-world overall survival (OS)
时间窗: From date of treatment start and until death, assessed up to ten years.
Describe the frequency and grading of adverse events of special interest (AESI), defined as described below.
时间窗: From date of treatment start until the date of start of next line of treatment or death, whichever came first, assessed up to 10 years
* Cytokine release syndrome (CRS) (ASTCT grade 1-5), * Infections (CTCAE grade 1-5) * Neurological adverse events (including, but not limited to, ICANS, peripheral sensory and/or motor neuropathy, neurocognitive and hypokinetic movement disorder) (CTCAE 5.0. grade 1-5). * Immune effector cell-associated hematotoxicity (ICAHT) (EHA/EBMT Consensus Grading 1-4)27 * Secondary malignancies, dysgeusia, skin- and nail adverse events, pain, hemophagocytic lymphohistiocytosis (HLH) and tumor lysis syndrome (CTCAE grade 1-5)
Frequency and grading of all other adverse events occurring during treatment according to CTCAE 5.0 (only grade 3 or higher will be reported).
时间窗: From start of treatment and until start of next treatment or death, assessed up to ten years.
Describe the microbiological pattern (positive cultures/PCR) of infections during treatment.
时间窗: From start of treatment and start of next treatment line or death, assessed up to ten years.
Describe the antibiotic resistance pattern of positive cultures.
时间窗: From start of treatment and start of next treatment line or death, assessed up to ten years.
Describe the prevalence of common airway viruses during treatment and at end-of-treatment.
时间窗: From date of start of treatment and until end of treatment, assessed up to ten years.
Determine the real-world use of antimicrobial prophylaxis (antibiotics, antivirals, vaccines, immunoglobulines) before and during therapy.
时间窗: From enrollment and until end of treatment, assessed up to ten years.
次要结局
未报告次要终点