This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT). This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR. The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments. The study is looking at several other research questions, including: * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against the linvoseltamab (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Phase 2
Time frame: Up to day 112
Severity of TEAEs
Phase 2
Time frame: Up to day 112
Achievement of Complete Response or better (≥CR) per International Myeloma Working Group (IMWG) criteria
Phase 2
Time frame: Up to day 112
Minimal Residual Disease (MRD) negative CR at 10^-5 per IMWG criteria
Phase 3
Time frame: Up to 12 months
Progression Free Survival (PFS) per IMWG
Phase 3
Time frame: Up to 5 years
Occurrence of TEAEs
Phase 2
Time frame: Up to 3.5 years
Severity of TEAEs
Phase 2
Time frame: Up to 3.5 years
Occurrence of Serious Adverse Events (SAEs)
Phase 2
Time frame: Up to 3.5 years
Severity of SAEs
Phase 2
Time frame: Up to 3.5 years
Occurrence of Cytokine Release Syndrome (CRS)
Phase 2
Time frame: Up to day 30
Severity of CRS
Phase 2
Time frame: Up to day 30
Occurrence of Cell-Associated Neurotoxicity Syndrome (ICANS)
Phase 2
Time frame: Up to day 30
Severity of ICANS
Phase 2
Time frame: Up to day 30
Achievement of objective response [Partial Response or better (≥PR)] per IMWG criteria
Time frame: Up to 5 years
Time to ≥PR per IMWG criteria
Time frame: Up to 5 years
Time to Very Good Partial Response or better (≥VGPR) per IMWG criteria
Time frame: Up to 5 years
Time to ≥CR per IMWG criteria
Time frame: Up to 5 years
Achievement of MRD negative (at 10^-5 sensitivity) CR per IMWG criteria
Time frame: Up to 5 years
Duration Of Response (DOR) of ≥PR per IMWG criteria
Time frame: Up to 5 years
Duration of ≥VGPR per IMWG criteria
Time frame: Up to 5 years
Duration of ≥CR per IMWG criteria
Time frame: Up to 5 years
PFS per IMWG criteria
Time frame: Up to 5 years
Second PFS (PFS2) per IMWG criteria
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Concentrations of total linvoseltamab in serum
Time frame: Up to 5 years
Occurrence of TEAEs
Phase 3
Time frame: Up to 5 years
Severity of TEAEs
Phase 3
Time frame: Up to 5 years
Occurrence of SAEs
Phase 3
Time frame: Up to 5 years
Severity of SAEs
Phase 3
Time frame: Up to 5 years
Occurrence of second primary malignancies
Phase 3
Time frame: Up to 5 years
Change from baseline in Global Health Status (GHS) per European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30)
Phase 3 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported Quality of Life (QoL). For GHS, scores range from 1 = "very poor" to 5 = "excellent" with higher scores indicating better functioning and positive changes from baseline indicate improvement.
Time frame: Up to 5 years
Change from baseline in physical functioning per EORTC QLQ-C30
Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life. Physical functioning is scored from 1 'very poor' to 5 'excellent,' with higher scores indicating better functioning; positive changes from baseline indicate improvement.
Time frame: Up to 5 years
Change from baseline in role functioning per EORTC QLQ-C30
Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life. Role functioning is scored from 1 'very poor' to 5 'excellent,' with higher scores indicating better functioning; positive changes from baseline indicate improvement.
Time frame: Up to 5 years
Change from baseline in pain per EORTC QLQ-C30
Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life. Pain is scored from 1 = "not at all" to 9 = "very much". Higher scores indicate higher symptom burden.
Time frame: Up to 5 years
Change from baseline in fatigue per EORTC QLQ-C30
Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life. Fatigue is scored from1 = "not at all" to 9 = "very much". Higher scores indicate higher symptom burden.
Time frame: Up to 5 years
Change from baseline in disease symptoms per EORTC QLQ- Multiple Myeloma Module 20 (MY20)
Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM. This 20-item questionnaire includes 6 items for disease symptoms. A high score for a symptom scale/item represents a high level of symptomatic problem.
Time frame: Up to 5 years
Change from baseline in treatment side effects per EORTC QLQ-MY20
Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM. This 20-item questionnaire includes 10 items for treatment side effects. A high score for a symptom scale/item represents a high level of symptomatic problem.
Time frame: Up to 5 years
Change from baseline in body image per EORTC QLQ-MY20
Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM. This 20-item questionnaire includes 1 item for treatment body image. A high score for a symptom scale/item represents a high level of symptomatic problem.
Time frame: Up to 5 years
Change from baseline in future perspective per EORTC QLQ-MY20
Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM. This 20-item questionnaire includes 3 items for treatment future perspective. A high score for a symptom scale/item represents a high level of symptomatic problem.
Time frame: Up to 5 years
Change from baseline in EuroQoL-5 Dimensions 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
Phase 3 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".
Time frame: Up to 5 years
Time to definitive deterioration in GHS per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in physical functioning per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in role functioning per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in pain per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in fatigue per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in disease symptoms per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in treatment side effects per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in body image per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in future perspective per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to definitive deterioration in EQ-5D-5L VAS
Phase 3
Time frame: Up to 5 years
Time to first improvement in GHS per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to first improvement in physical functioning per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to first improvement in role functioning per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to first improvement in pain per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to first improvement in fatigue per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Time to first improvement in disease symptoms per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to first improvement in treatment side effects per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to first improvement in body image per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to first improvement in future perspective per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Time to first improvement in EQ-5D-5L VAS
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in GHS per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in physical functioning per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in role functioning per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in pain per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in fatigue per EORTC QLQ-C30
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in disease symptoms per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in treatment side effects per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in body image per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Proportion with clinically meaningful improvement in future perspective per EORTC QLQ-MY20
Phase 3
Time frame: Up to 5 years
Proportion of clinically meaningful improvement in EQ-5D-5L VAS
Phase 3
Time frame: Up to 5 years
Mean proportion of time with high side effect bother as measured by Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5)
Phase 3 FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).
Time frame: Up to 5 years
Proportion of patients with high side effect bother as measured by FACIT- Item GP5
Phase 3
Time frame: Up to 5 years
Occurrence of Anti-Drug Antibody (ADA) to linvoseltamab in serum
Phase 3
Time frame: Up to 5 years
Magnitude of ADA to linvoseltamab in serum
Phase 3
Time frame: Up to 5 years
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