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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Relapsed and/or Refractory Multiple Myeloma (RRMM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, South Korea, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies. The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options. 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)
Interventions
- Drug Linvoseltamab
Administered per the protocol - Drug Carfilzomib
Administered per the protocol - Drug Daratumumab
Administered per the protocol - Drug Dexamethasone
Administered per the protocol - Drug Pomalidomide
Administered per the protocol - Drug Bortezomib
Administered per the protocol
Primary outcome measures
- Occurrence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 5 years]
- Severity of TEAEs [Time frame: Up to 5 years]
- Occurrence of Adverse Events of Special Interest (AESI) [Time frame: Up to 5 years]
- Severity of AESIs [Time frame: Up to 5 years]
- Occurrence of Serious Adverse Events (SAEs) [Time frame: Up to 5 years]
- Severity of SAEs [Time frame: Up to 5 years]
- Minimal Residual Disease (MRD)-negative Complete Response (CR) [Time frame: At 12 months]
- Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC [Time frame: Up to 5 years]
Secondary outcome measures (12)
- Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) [Time frame: Up to 28 days]
- Timing of grade ≥2 CRS [Time frame: Up to 28 days]
- Overall Survival (OS) [Time frame: Up to 7 years]
- Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC [Time frame: Up to 5 years]
- Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC [Time frame: Up to 5 years]
- Achievement of CR or better per IMWG response criteria as determined by BIRC [Time frame: Up to 5 years]
- Duration Of Response (DOR) as per IMWG response criteria [Time frame: Up to 5 years]
- Time To Progression (TTP) as per IMWG response criteria [Time frame: Up to 5 years]
- Time To Next Treatment (TTNT) [Time frame: Up to 5 years]
- Second PFS [Time frame: Up to 5 years]
- MRD-negative CR criteria at any time [Time frame: Up to 5 years]
- Time to PR IMWG response category [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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 inclusion/exclusion criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 7 centers
- Chonnam National University Hwasun Hospital — Hwasun
- Seoul National University Hospital — Seoul
- Severance Hospital; Division of Hematology — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul
- Ulsan University Hospital — Ulsan
United Kingdom · 6 centers
- Aberdeen Royal Infirmary — Aberdeen
- Royal Cornwall Hospital National Health Service (NHS) Foundation Trust — Truro
- University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology — Plymouth
- Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust — Norwich
- University Hospitals Birmingham NHS Trust, Center for Clinical — Birmingham
- Ninewells Hospital and Medical School — Dundee
United States · 4 centers
- Emory Winship Cancer Institute — Atlanta
- Memorial Sloan Kettering Cancer Center — New York
- OhioHealth — Columbus
- University of Texas Health Science Center, Houston — Houston
Australia · 3 centers
- Mater Misericordiae Ltd — Brisbane
- Gold Coast Hospital and Health Service — Southport
- Alfred Hospital — Melbourne
Identifiers
NCT: NCT07222761 · R5458-ONC-2246 · 2024-519504-27-00