An Open-label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab plus Carfilzomib versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Part 1 - To evaluate the safety and tolerability of condensed step-up dosing for linvoseltamab and linvoseltamab + carfilzomib treatment and select the RP3Rs for Arm A and Arm B in Part 2
Part 2 (dual) - To compare the proportion of participants who achieve MRD-negative CR at 12 months in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C) Part 2 (dual) - To compare PFS in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C)
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
- 否
入选标准
- •Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- •Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy
- •NOTE: Other protocol defined inclusion criteria apply
排除标准
- •Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
- •Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
- •History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
- •NOTE: Other protocol defined exclusion criteria apply
结局指标
主要结局
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
Part 1 - Severity of TEAEs
Part 1 - Severity of TEAEs
Part 1 - Occurrence of Adverse Events of Special Interest (AESI)
Part 1 - Occurrence of Adverse Events of Special Interest (AESI)
Part 1 - Severity of AESIs
Part 1 - Severity of AESIs
Part 1 - Occurrence of Serious Adverse Events (SAEs)
Part 1 - Occurrence of Serious Adverse Events (SAEs)
Part 1 - Severity of SAEs
Part 1 - Severity of SAEs
Part 2 - Minimal Residual Disease (MRD) -negative Complete response (CR)
Part 2 - Minimal Residual Disease (MRD) -negative Complete response (CR)
Part 2 - Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC
Part 2 - Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC
次要结局
- Part 1 - Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)
- Part 1 - Timing of grade ≥2 CRS
- Part 2 - Overall Survival (OS)
- Part 2 - Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC
- Part 2 - Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC
- Part 2 - Achievement of CR or better per IMWG response criteria as determined by BIRC
- Part 2 - Duration Of Response (DOR) as per IMWG response criteria
- Part 2 - Time To Progression (TTP) as per IMWG response criteria
- Part 2 - Time To Next Treatment (TTNT)
- Part 2 - Second PFS
- Part 2 - MRD-negative CR criteria at any time
- Part 2 - Time to PR IMWG response category
- Part 2 - Time to VGPR IMWG response category
- Part 2 - Time to CR IMWG response category
- Part 2 - Time to stringent Complete Response (sCR) IMWG response category
- Part 2 - Sustained of MRD-negative CR
- Part 2 - Duration of MRD-negative CR
- Part2 - Occurrence of TEAEs
- Part 2 - Severity of TEAEs
- Part 2 - Occurrence of AESIs
- Part 2 - Severity of AESIs
- Part 2 - Occurrence of SAEs
- Part 2 - Severity of SAEs
- Part 2 - Concentrations of linvoseltamab in serum over time
- Part 2 - Incidence of Antidrug Antibodies (ADAs) to linvoseltamab
- Part 2 - Magnitude of ADAs to linvoseltamab
- Part 2 - Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time
- Part 2 - Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30)
- Part 2 - Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30
- Part 2 - Change from baseline in Role Functioning (RF), per EORTC QLQ-C30
- Part 2 - Change from baseline in pain, per EORTC QLQ-C30
- Part 2 - Change from baseline in fatigue, per EORTC QLQ-C30
- Part 2 - Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])
- Part 2 - Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20
- Part 2 - Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)
- Part 2 - Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.