Informations générales (source: ClinicalTrials.gov)
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3) (LINKER-MM3)
Interventional
Phase 3
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
septembre 2023
avril 2033
11 avril 2025
This study is researching an experimental drug called linvoseltamab, also called
REGN5458.
Linvoseltamab has previously been studied by itself (without other cancer drugs) in
participants who had advanced multiple myeloma that returned and needed to be treated
again after many other therapies had failed. These participants were no longer benefiting
from standard medications and had no good treatment options. In that study, some
participants who were treated with linvoseltamab had improvement of their myeloma
(shrinkage of their tumors), including some participants who had complete responses (that
is, the treatment got rid of all evidence of myeloma in their bodies).
This study is focused on participants who have multiple myeloma that has returned or
needs to be treated again after one to four prior treatments and have standard cancer
treatment options available to them. The aim of this study is to see how safe and
effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab,
pomalidomide and dexamethasone, (called EPd) in participants who have returned after
having received prior treatment that included lenalidomide, a proteosome inhibitor, and
(for participants in some countries) a cluster of differentiation 38 (CD38) antibody.
Half of the participants in this study will get linvoseltamab, and the other half will
get EPd.
This study is looking at several other research questions, including:
- How long participants benefit from receiving linvoseltamab compared with EPd
- How many participants treated with linvoseltamab or EPd have improvement of their
multiple myeloma and by how much
- What side effects happen from taking linvoseltamab compared to EPd
- How long participants live while receiving treatment or after treatment with
linvoseltamab compared to EPd
- If there is any improvement in pain after treatment with linvoseltamab compared to
EPd
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 07/02/2025 12:36:11 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Jean-Marie MICHOT | 13/02/2024 17:23:51 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:11:54 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | 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 Francois Magendie - 33600 - Pessac - Gironde - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Lille - 59037 - Lille - Hauts De France - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL) - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis, APHP - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Age 18 years or older (or legal adult age in the country) at the time of the
screening visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG
2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion
with the Medical Monitor.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies,
including lenalidomide and a proteasome inhibitor and demonstrated disease
progression on or after the last therapy as defined by the 2016 IMWG criteria.
Participants who have received only 1 line of prior line of antimyeloma therapy must
be lenalidomide refractory, as described in the protocol.
Note: Participants in Israel also must have previously received a CD38 antibody.
Participants in the EU and the UK must have previously received 2 to 4 prior lines
of therapy, including a CD38 antibody.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG
response assessment criteria, as described in the protocol
5. Adequate hematologic function and hepatic function within 7 days of randomization,
as well as adequate renal and cardiac function and corrected calcium
6. Life expectancy of at least 6 months
Key
1. Age 18 years or older (or legal adult age in the country) at the time of the
screening visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG
2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion
with the Medical Monitor.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies,
including lenalidomide and a proteasome inhibitor and demonstrated disease
progression on or after the last therapy as defined by the 2016 IMWG criteria.
Participants who have received only 1 line of prior line of antimyeloma therapy must
be lenalidomide refractory, as described in the protocol.
Note: Participants in Israel also must have previously received a CD38 antibody.
Participants in the EU and the UK must have previously received 2 to 4 prior lines
of therapy, including a CD38 antibody.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG
response assessment criteria, as described in the protocol
5. Adequate hematologic function and hepatic function within 7 days of randomization,
as well as adequate renal and cardiac function and corrected calcium
6. Life expectancy of at least 6 months
Key
1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein,
and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28
days before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem
cell transplantation within 12 weeks of the start of study treatment. Participants
who have received an allogeneic transplant must be off all immunosuppressive
medications for 6 weeks without signs of graft-versus-host disease. Steroids at
doses equivalent to suppletion doses may be acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note:
BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML,
or history of a neurocognitive condition or central nervous system (CNS) movement
disorder (Parkinson's disease or Parkinsonism).
8. Any infection requiring hospitalization or treatment with IV anti-infectives within
2 weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus
(HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in
the protocol 10 Cardiac ejection fraction <40%.
NOTE: Other protocol defined inclusion/exclusion criteria apply