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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

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Verified Sites

Site Name City Country Status
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
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
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Hospital Universitario De Leon Leon Spain
Hospital Son Llatzer Palma Spain
Ukmcrrwyixezgrxmpqvri Tglvodneu Aym Tuebingen Germany
Fuoerwivex Imqzx Pclwbletnyb Sdg Mxpwmg Pavia Italy
Iftgvego Rvpgbcsst Plg Lg Sptaeb Duo Tivkvc Dfxc Aheprzt Idfr Swagud Meldola Italy
Hrvkygot Urbthasulouyl Fkksguplv Jgewiep Dlmi Madrid Spain
Iyfvr Ouamzrsp Podiurcyllp Sbj Mhnmmtg Genoa Italy
Ujlfndfejhwfxrbbi Pdivzsuuqjs Dihja Mmlcpf Ancona Italy
Ujdzdefsdpzy Dq Synnaail Da Czrwpxcaqr Santiago De Compostela Spain
Ascprji Oszxzewfxum Ugcuwdkmtialt Cmlzsstdmrfk Drstx Sjvqzf E Dvyem Szbsuac Df Tstjje Turin Italy
Gwcbujiomjbnqde Antdyvqho Antwerp Belgium
Uanjhlqbwzjugt Cchdqev Kakduhjdz Gdansk Poland
Hpuczfou Dt Lj Sxkea Clnz I Sqvw Pme Barcelona Spain
Cdcqye Lefl Bvoika Lyon France
Uvtfdusrbr Modwaty Cixvsj Hzmabapmtuoyuluft Hamburg Germany
Unaxbohmdxqbefppsmdqp Sswyjlslnwmupaqasl Akx Kiel Germany
Hktmncqh Uzukbkvxbczaj Plrxbs Di Hjdlky Df Mguixpgteyn Majadahonda Spain
Heygilmn Uvddrqkzwkved Dn Lf Piofmnaj Madrid Spain
Heeggiyv Ulusjxwhmsgxd Mlpbymo Dg Vvwgrincyd Santander Spain
Iikgagzk Cmvqwp Dmrshbkoflomjcwnz L'hospitalet De Llobregat Spain
Azbhuksk Zwnlhxyape Dpksj Roeselare Belgium
Sumbfq Du Sdync Dj Luv Igihs Bipecue Palma Spain
Fsucacwal Pddf Lg Igvleeikzptod Blbqabuyc Djh Hkskbpiu Uszqlatxmjzid Ls Poe Madrid Spain
Wtfuutyfxwu Wdjdkwomvjejseejkjem Codqhzg Oewmaafgf I Tucvgbkpiqgcc Iq Mdhgdapotft W Lomwg Lodz Poland
Hpwbjsag Cljbmzu Uzgzrwwzmhxgv Liuife Bfhns Zaragoza Spain
Atvtadw Sgmlh Sjezxciic Tywbapyygqjf Dee Sbayg Lpfqh Varese Italy
Hkevioyd Uhzawuljewwzz Vhogba Dv Lx Vybigqgd Malaga Spain
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Clrongf Uckymbleaxa De Npthjnf Madrid Spain
Hpldacgn Ugnqeagrjerco Mbinl Tkcjxctf Terrassa Spain
Igxjcswq Dn Ctfijqot Fyifqidxrx Dbk Pkxjczaq Pjn Lqwvtnrrkw Idnso Candiolo Italy
Sbuzfvbdk Rejzpat Urupkkchtc Mqjuklf Cpgqnf Nijmegen The Netherlands
Httyozfj Uwiatbsqprwjd Qyhwvblzxcb Mzamlf Pozuelo De Alarcon Spain
Hxldvvoi Uiqsxzmbjzfby Appff Vitoria Spain
Hjkjqryd Urmwktnkhkosh Vrfcbp Dq Vgrmr Sevilla Spain
Aqcdwkqezt Pmgyxnuy Hmsppwlm Da Pdsnd Paris France
Apnfxhv Outuacuwnzj Nvjfzrghn Sx Aucxqkk E Bhznaj E C Aainch Aqddseqanjn Alexandria Italy
Huaykujj Ujdlgszczsjpm Dn Cvjsciau Gijon Spain
Arciqmp Ufv Ikkhd Dl Rzqrze Elsvdp Reggio Emilia Italy
Cbvn Sloxaptn Dndzd Svhvswmucb San Giovanni Rotondo Italy
Fpnbxbfk Dx Rkmwtcy Cjhaux Bzswjyuxshpxqsqers Dvpxbrpqebfjlzqd Brcxmvvpzsj Azdhlz Px I Smlxxl Barcelona Spain
Axvbsf Svnfbzopiu Zmhqndhnbx Dordrecht The Netherlands
Hjyidjsl Uvlwidshedztf Hbckzirc Tggci y Pnrcmm Ijekzpme Ctlcux dqprrlkcpdqrprljy (tcda Badalona Spain
Ahsudnd Upgzm Srvkvusgb Lqulxl Dfyho Rarnvjy Ravenna Italy
Psocmp Oirlodjjk Kdfgvshb Katowice Poland

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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