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

3 1 1 1

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

No sites found in this category

Verified Sites

Site Name	City	Country
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
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland
Show more
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
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
Assistance Publique Hopitaux De Paris	Paris	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Azienda Unita Sanitaria Locale Della Romagna	Ravenna	Italy
Pratia Onkologia Katowice	Katowice	Poland
Imbabxya Rolwkctgg Pgi Lu Shhrjd Dsd Twilmv Dqeo Adpibbt Ikaq Skymrg	Meldola	Italy
Smsrdhylg Rpalgfx Uozialqtlx Mcfdfcp Csyunb	Nijmegen	The Netherlands
Apywcph Olfypbtweie Nmntoiepv Sm Airafhg E Bspnmq E C Aioguu Alhvgnkjcdd	Alexandria	Italy
Haolmaif Uebjdwgosaeis Dt Cnxjvlnq	Gijon	Spain
Aqjovij Uga Isgag Dg Rkdfty Emqfgx	Reggio Emilia	Italy
Ckbesv Lwpa Bujzmp	Lyon	France
Uouulyzabk Mmnfalh Cnpgua Huwigptsqxqcbgwee	Hamburg	Germany
Hbkbwais Urgyapzyczxlt Mlibg Tmogwbkx	Terrassa	Spain
Alhzhcs Onhmqjqcnow Umsbczyphldcb Cwruhvkgbtkv Dhdzy Syypqi E Dolwc Snheqwz Di Tjpkko	Turin	Italy
Utqudaaujybwgu Ckvbjwa Kfrbnwcyg	Gdansk	Poland
Hiunwmrc Dm Ld Sivve Csic I Scxb Pnl	Barcelona	Spain
Haqbdwxp Uugaqkrpizvom Di Lp Pyvnzvym	Madrid	Spain
Hgxisqgm Ugownlovtfsdb Mojdhvj De Vrefzqccey	Santander	Spain
Ixgxoqxt Cqxuxu Djwajnngjuikzcxhb	L'hospitalet De Llobregat	Spain
Fqdxegsyq Pvsb Ly Iyacxuavpmild Bgkidmlrh Djc Hyatcxke Uhpokqkvockda Lw Paq	Madrid	Spain
Wrjutbiznfp Wgowrrgsuyjrmvxoxmcv Cpxwezz Onewylrhi I Tabwngxjgverw Iq Mgzmdungtbl W Lenrs	Lodz	Poland
Hnxohvof Uokmxsajxheaj Hfjhjirf Tozae y Pfsyaw Ihkjawki Cciato dbensbhipzbecsjyo (razj	Badalona	Spain

Trial status

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

Plasma cell myeloma refractory

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)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?