Multiple Myeloma Clinical Trial

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Summary

The 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 the 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 this form), one of these standard treatment options. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. Both linvoseltamab and EPd will be referred to as "study drugs" in this form.

The 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

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
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.

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.

Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves
Life expectancy of at least 6 months

Key Exclusion Criteria:

Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Prior treatment with elotuzumab and/or pomalidomide
Participants with known MM brain lesions or meningeal involvement
Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
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.
Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder.
Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
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.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

380

Study ID:

NCT05730036

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 88 Locations for this study

See Locations Near You

UCLA
Los Angeles California, 90095, United States
Norton Cancer Institute - St. Matthews Campus
Louisville Kentucky, 40207, United States
Stony Brook University Hospital
Stony Brook New York, 11794, United States
Levine Cancer Center
Charlotte North Carolina, 28204, United States
Kaiser Permanente Northwest
Portland Oregon, 97227, United States
University of Washington-Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Royal Brisbane Hospital
Herston Queensland, 4029, Australia
Integrated Clinical Oncology Network
South Brisbane Queensland, 4101, Australia
University Hospital Geelong
Geelong Victoria, 3220, Australia
Austin Hospital
Heidelberg Victoria, 3084, Australia
St Vincents Hospital Melbourne
Melbourne Victoria, 3065, Australia
Hospital Sao Rafael
Salvador Bahia, 41253, Brazil
Associacao Dr Bartholomeu Tacchini (Instituto Tacchini De Pesquisa Em Saude)
Bento Goncalves Rio Grade Do Sul, 95700, Brazil
Hospital Mae de Deus Center
Porto Alegre Rio Grande Do Sul, 90110, Brazil
ANIMI
Lages Santa Catarina, 88501, Brazil
AC Camargo Cancer Center
São Paulo , 01509, Brazil
Instituto D'Or de Pesquisa e Ensino
São Paulo , 04501, Brazil
The Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hopital Haut leveque-service d'Hematologie
Pessac Gironde, 33600, France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif Paris, 94800, France
Centre Hospitalier Universitaire (CHU) de Lille
Lille , 59037, France
Hopital Universitaire Necker
Paris , 75015, France
Hopital Saint Antoine
Paris , 75571, France
The Chaim Sheba Medical Center
Ramat Gan Hamerkaz, 52656, Israel
Rambam health care Campus
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo Foggia, 71013, Italy
Istituto Romagnolo per lo Studio Dei Tumori "Dino Amadori"
Meldola Forli Cesena, 47014, Italy
Ospedale Di Circolo - Fondazione Macchi
Varese Lombardy, 21100, Italy
AOU Ospedali Riuniti di Ancona
Ancona , 60126, Italy
Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi
Bologna , 40138, Italy
IRCCS Fondazione Policlinico San Matteo Pavia
Pavia , 27100, Italy
U.O.C. Ematologia Ospedale Santa Maria delle Croci
Ravenna , 48121, Italy
AUSL IRCCS OF Reggio Emilia
Reggio Emilia , 42123, Italy
University of Torino, Division of Hematology
Torino , 10126, Italy
Candiolo Cancer Institute, FPO, IRCCS
Turin , 10060, Italy
Inje University Busan Paik Hospital
Busan , 47392, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun , 58128, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 28265, Korea, Republic of
Jeonbuk National University Hospital
Jeonju , 54907, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Marys Hospital
Seoul , 06591, Korea, Republic of
Radboud umc
Nijmegen Gelderland, 6500 , Netherlands
Albert Schweitzer Hospital
Dordrecht Zuid-Holland, 3318 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdańsk Pomorskie, 80-21, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
National University Hospital
Kent Ridge , 11907, Singapore
Singapore General Hospital
Singapore , 16985, Singapore
Hospital de Cabueñes
Gijon Asturias, 33203, Spain
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
Hospital universitari Son LLatzer
Palma de Mallorca Baleares, 07198, Spain
Institut Catala dOncologia, Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitario Marqués de Valdecilla
Santander Cantabria, 39008, Spain
Hospital Universitari Son Espases
Palma de Mallorca Islas Baleares, 07120, Spain
Hospital Universitario Quirónsalud Madrid
Pozuelo Madrid, 28223, Spain
Hospital Universitario de Navarra
Pamplona Navarra, 31008, Spain
Hospital Gral. Universitari D'Alacant Y C.E Babel (Hospital General De Alicante)
Alicante , 03010, Spain
Hospital de la Santa Creu I de Sant Pau
Barcelona , 08026, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitari de Girona Dr. Josep Trueta - Institut Catala d'Oncologia
Girona , 17007, Spain
Universitary Hospital La Princesa
Madrid , 28006, Spain
Clinica Universidad de Navarra - Sede Madrid
Madrid , 28027, Spain
Hospital Universitario La Paz
Madrid , 28029, Spain
Hospital Fundación Jimenez Diaz
Madrid , 28040, Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela , 15706, Spain
University Hospital La Fe
Valencia , 46026, Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza , 50009, Spain
Changhua Christian Hospital
Changhua City Changhua County, 500-0, Taiwan
Hualien Tzu Chi Hospital
Hualien City , 97047, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung , 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 83301, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Chang Gung Memorial Hospital- Linkou Branch
Taoyuan , 333, Taiwan
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
Addenbrooke's Hospital
Cambridge , CB2 0, United Kingdom
St Bartholomew's Hospital
London , EC1A , United Kingdom
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London , SE1 9, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London , W12 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

380

Study ID:

NCT05730036

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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