NCT07393282招募中3 期
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 15
- 主要终点
- Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
研究概览
简要总结
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.
The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
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
- •Eastern Cooperative Oncology Group performance status score ≤1
- •SMM diagnosis per IMWG criteria as defined in the protocol
- •Meets HR-SMM criteria by 1 of the risk models as defined in the protocol
排除标准
- •Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol
- •Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma
- •History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
- •History of a seizure within the 12 months of randomization
- •Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Linvoseltamab
Experimental
干预措施: Linvoseltamab (Drug)
Daratumumab
Active Comparator
干预措施: Daratumumab (Drug)
结局指标
主要结局
Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
时间窗: Up to 5 years
Biochemical PFS per IMWG criteria
时间窗: Up to 5 years
次要结局
- Duration of MRD-negative CR(Up to 3 years)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to 3 years)
- Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria(Up to 3 years)
- Severity of TEAEs(Up to 3 years)
- Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria(Up to 3 years)
- Achievement of Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria(Up to 3 years)
- Best Overall Response (BOR) per IMWG criteria(Up to 3 years)
- Achievement of MRD-negativity(Up to 3 years)
- Sustained MRD-negativity(Up to 3 years)
- Occurrence of Serious Adverse Events (SAEs)(Up to 3 years)
- Change from baseline score in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) scale(Up to 5 years)
- Change from baseline score in EORTC QLQ-C30 physical functioning scale(Up to 5 years)
- Change from baseline score in EORTC QLQ-C30 role functioning scale(Up to 5 years)
- Change from baseline score in EORTC QLQ-C30 emotional functioning scale(Up to 5 years)
- Change from baseline score in EORTC QLQ-C30 pain scale(Up to 5 years)
- Change from baseline score in EORTC QLQ-C30 fatigue scale(Up to 5 years)
- Change from baseline score in EORTC IL478 future perspectives scale(Up to 5 years)
- Change from baseline score in EuroQoL-5 Dimensions 5-Level Questionnaire Visual Analogue Scale (EQ-5D-5L VAS )(Up to 5 years)
- Concentrations of linvoseltamab in serum(Up to 5 years)
- Occurrence of Anti-Drug Antibodies (ADAs) to linvoseltamab in serum(Up to 5 years)
- Magnitude of ADA to linvoseltamab in serum(Up to 5 years)
- Time to death(Up to 9 years)
- Duration Of Response (DOR) per IMWG criteria(Up to 5 years)
- Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5) responses(Up to 5 years)
- Change from baseline in FACIT- Item GP5 score(Up to 5 years)
研究者
研究点 (15)
Loading locations...
相似试验
招募中
3 期
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy with Standard-of-Care Combination Regimens in Adult Participants with Relapsed/Refractory Multiple Myeloma (RRMM)2024-519504-27-00Regeneron Pharmaceuticals Inc.40
招募中
2 期
A Trial to Learn if Linvoseltamab is Safe and Works in Adults with Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)2023-507809-34-00Regeneron Pharmaceuticals Inc.23
招募中
2 期
A Window of Opportunity Trial To Learn If Linvoseltamab Is Safe And Well Tolerated, And How Well It Works In Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received TreatmentMultiple Myeloma2022-500800-24-00Regeneron Pharmaceuticals Inc.76
招募中
2 期
A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILDPulmonary HypertensionNCT07333183Pulmovant, Inc.20
已完成
1 期
A Phase 1, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics Of Mavodelpar In Subjects With Impaired Hepatic Function2023-504007-91-00Reneo Pharmaceuticals Inc.32