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Study Comparing Linvoseltamab to Elotuzumab, Pomalidomide, and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called Relapsed/Refractory Multiple Myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study aims to compare the effectiveness of a new treatment called Linvoseltamab (also known by its code name REGN5458) with a combination of three existing medications: Elotuzumab, Pomalidomide, and Dexamethasone. Linvoseltamab is a type of medication known as a bispecific antibody, which is designed to target specific proteins on cancer cells to help the immune system attack them.

Participants in the study will be randomly assigned to receive either Linvoseltamab or the combination of Elotuzumab, Pomalidomide, and Dexamethasone. The study will observe how long participants live without their disease getting worse, which is known as progression-free survival. The trial will also monitor other health outcomes, such as overall survival and the response of the disease to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

The study will take place over a period of time, with regular check-ups and assessments to monitor the participants’ health and the effectiveness of the treatments. The goal is to gather information that could lead to better treatment options for people with Relapsed/Refractory Multiple Myeloma. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a specific performance status, and having received certain prior treatments for multiple myeloma.

2 randomization

Participants are randomly assigned to one of two treatment groups: one receiving linvoseltamab and the other receiving a combination of elotuzumab, pomalidomide, and dexamethasone.

3 treatment administration

For those in the linvoseltamab group, the medication is administered as an infusion. The frequency and duration of administration are determined by the study protocol.

Participants in the combination group receive elotuzumab via infusion, pomalidomide orally in capsule form, and dexamethasone as an oral tablet or injection. Dosages and schedules are specified in the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical exams, blood tests, and other necessary evaluations.

Participants are required to attend scheduled follow-up visits to ensure ongoing assessment of their health and treatment efficacy.

5 completion of study participation

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

Participants may be asked to provide feedback on their experience and any changes in their quality of life.

Who Can Join the Study?

  • Must be 18 years or older (or the legal adult age in your country) at the time of the screening visit.
  • Must have an ECOG performance status of 0 or 1. This is a scale that measures how well you can perform daily activities. If your status is 2 due to local symptoms of myeloma, like pain, you might still be eligible after discussion with the Medical Monitor.
  • Must have Multiple Myeloma (MM) and have received at least 1 and no more than 4 previous treatments for MM, including specific drugs like lenalidomide and a proteasome inhibitor. You must have shown disease progression after the last treatment. If you have only had 1 previous treatment, you must be lenalidomide refractory, meaning the disease did not respond to lenalidomide or worsened within 60 days of the last dose. In the EU and UK, you must have had 2 to 4 previous treatments, including a CD38 antibody.
  • Must have measurable disease for response assessment, which means the disease can be measured to see how it responds to treatment.
  • Must have adequate function of blood, liver, kidneys, and heart, and enough healthy bone marrow.
  • Must have a life expectancy of at least 6 months.
  • Other specific criteria defined in the study protocol may apply.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with Relapsed Refractory Multiple Myeloma cannot participate. This is a type of cancer that affects the blood and bone marrow and has returned after treatment or is not responding to treatment.
  • Patients who have not been previously treated with CD38 antibodies cannot participate. CD38 antibodies are a type of medication used to treat certain blood cancers.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and includes adults.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Institut Gustave Roussy Villejuif France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Assistance Publique Hopitaux De Paris Paris France
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Pratia Hematologia Sp. z o.o. Katowice Poland
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hospital Universitario De Leon Leon Spain
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Son Llatzer Palma Spain
Hospital Universitario Araba Vitoria Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Assistance Publique Hopitaux De Paris Paris France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hopital Beaujon Clichy France
Algemeen Ziekenhuis Delta Roeselare Belgium
Servei De Salut De Les Illes Balears Palma Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Institut Curie – Site Saint-Cloud Saint-Cloud France
Hospital Universitario Virgen De La Victoria Malaga Spain
Cwinvrusv Utlcjdxbljjbrl Sihkufofi Woluwe-Saint-Lambert Belgium
Irpqvzct Ragvvkifx Pcf Lj Sslchg Dix Tpxdbg Dbnx Apueqsg Ixkw Sgguql Meldola Italy
Sykdtfbmh Rroaoxg Upiasocemq Muwwspu Ctvdfc Nijmegen The Netherlands
Aiirayq Ormaknkwout Nshqylbkp Sd Aljdilj E Bhvvat E C Aivaqo Axzkeipdeol Alexandria Italy
Hdnessxd Uuunqymmocuob Du Cqmsbxsh Gijon Spain
Atbgjoa Uag Ihtfi Db Rwqrrw Eglvjg Reggio Emilia Italy
Chhhso Ldnc Bzaypj Lyon France
Uahextxeff Mxepqvw Cbsjon Hvyupxctoygavmfhk Hamburg Germany
Hlrrbydo Uajmfzgftdhft Mhkrk Tpvvenwh Terrassa Spain
Ahthgfv Ofecgrkaiuv Uphapoubjtgns Cxogkcsxssta Dakdz Swfsnq E Dflap Shvisva Da Tyzkrp Turin Italy
Ujkjrcinltfglk Cwfaght Knsbjpmvd Gdansk Poland
Hicnwcea Dz Lv Sztaa Cbye I Sffo Pxs Barcelona Spain
Hjudjrli Uiavwdnorcaxv Df Ls Pzlbpkjg Madrid Spain
Htacezql Uckhslxpedwpx Mktjsvp Dk Vekimxaosu Santander Spain
Inqzaagu Cxrzza Dzxoyoedwziqdfror L'hospitalet De Llobregat Spain
Fojeunlpa Pwav Lk Iifuetfzmtsqz Bocsgmiry Dqd Hfnwldpr Ugzuyeufodpmt Lv Pwq Madrid Spain
Wulkzjupavp Wphrbtpjqjducibmxubx Cajyouk Oagiafyli I Thshnaryajdko Iu Mirqjcweyux W Lzwru Lodz Poland
Hbwcogds Uolqvksfmfits Hyhlczmm Tvddj y Pvpxsx Igoihztp Ctjdgc dvtzkmhljtqsqjcgb (ptpn Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.05.2023
France France
Not recruiting
31.05.2023
Germany Germany
Not recruiting
31.05.2023
Italy Italy
Not recruiting
31.05.2023
Poland Poland
Not recruiting
31.05.2023
Spain Spain
Not recruiting
31.05.2023
The Netherlands The Netherlands
Not recruiting
31.05.2023

Trial locations

Investigated drugs:

Linvoseltamab: This is a bispecific antibody designed to target two specific proteins, BCMA and CD3. It is used in this study to treat patients with relapsed or refractory multiple myeloma. The medication works by engaging the immune system to attack and destroy cancer cells.

Elotuzumab: This is a monoclonal antibody that targets a protein called SLAMF7 on the surface of myeloma cells. It helps the immune system recognize and kill these cancer cells. In this study, it is used in combination with other medications to treat multiple myeloma.

Pomalidomide: This medication is an immunomodulatory drug that helps the immune system fight cancer. It works by affecting the growth of cancer cells and enhancing the body’s immune response against them. It is used in combination with other drugs in this trial for treating multiple myeloma.

Dexamethasone: This is a corticosteroid medication that helps reduce inflammation and suppresses the immune system. In the context of this study, it is used to help manage symptoms and enhance the effectiveness of other cancer treatments in patients with multiple myeloma.

Investigated diseases:

Relapsed Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer returns after treatment or does not respond to treatment. It typically progresses by causing damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease is characterized by the uncontrolled growth of abnormal plasma cells, leading to a decrease in the production of normal blood cells. Over time, this can result in complications like anemia, bone fractures, and kidney problems.

Trial ID:
2022-501396-62-00
Protocol code:
R5458-ONC-2245
NCT ID:
NCT05730036
Trial Phase:
Therapeutic confirmatory (Phase III)

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