Informations générales (source: ClinicalTrials.gov)
Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma
Interventional
Phase 1/Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2023
novembre 2035
13 septembre 2025
This study is researching an experimental drug called linvoseltamab (called "study
drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM)
who are eligible for high dose chemotherapy with autologous stem cell transplantation
(transplant-eligible) or ineligible for autologous stem cell transplantation
(transplant-ineligible).
The aim of this clinical trial is to study the safety, tolerability (how the body reacts
to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants
with NDMM as a first step in determining if the study drug has a role in the treatment of
NDMM.
This study consists of 2 phases:
- In Phase 1, the study drug will be given to participants to study the side effects
of the study drug and to establish the regimen (initial doses and full dose) of the
study drug to be given to participants in Phase 2.
- In Phase 2, the study drug will be given to more participants to continue to assess
the side effects of the study drug and to evaluate the ability of the study drug to
shrink the tumor (multiple myeloma) in participants with NDMM.
The study is looking at several research questions, including:
- What side effects may happen from taking linvoseltamab?
- What the right dosing regimen is for linvoseltamab?
- How many participants treated with linvoseltamab have improvement of their disease
and for how long?
- The effects of linvoseltamab study treatment before and after transplant
- How much linvoseltamab is in the blood at different times?
- Whether the body makes antibodies against linvoseltamab (which could make the drug
less effective or could lead to side effects).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire (CHU) de Poitiers - 86021 - Poitiers - Nouvelle-Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) Montpellier - 342950 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU De Lille - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma
Working Group (IMWG) diagnosis criteria
3. Measurable disease, according to the 2016 IMWG response criteria, as defined in the
protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative
radiation and up to 1 month of single-agent corticosteroids, with washout periods as
per the protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal
and cardiac function as defined in the protocol
6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac
function to be considered transplant-eligible. The specific thresholds for adequate
organ function are as per institutional guidance.
Key
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma
Working Group (IMWG) diagnosis criteria
3. Measurable disease, according to the 2016 IMWG response criteria, as defined in the
protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative
radiation and up to 1 month of single-agent corticosteroids, with washout periods as
per the protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal
and cardiac function as defined in the protocol
6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac
function to be considered transplant-eligible. The specific thresholds for adequate
organ function are as per institutional guidance.
Key
1. Receiving any concurrent investigational agent with known or suspected activity
against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/
Transmembrane activator and calcium modulator and cyclophilin ligand interactor
(TACI)/BCMA axis
2. Known central nervous system (CNS) involvement with MM, known or suspected
progressive multifocal leukoencephalopathy (PML), a history of neurocognitive
conditions, or CNS movement disorder, or history of seizure within 12 months prior
to study enrollment
3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or
hypercalcemia not responsive to standard medical interventions), in urgent need of
treatment with chemotherapy
4. Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL)
amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)
Note: Other protocol-defined Inclusion/Exclusion criteria apply