Study comparing daratumumab, lenalidomide and dexamethasone followed by linvoseltamab versus continued initial treatment in newly diagnosed multiple myeloma patients

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What is this study about?

This clinical trial focuses on treating patients with newly diagnosed Multiple Myeloma who are not eligible for transplant. The study compares two treatment approaches. The first approach uses a combination of Daratumumab, Lenalidomide, and Dexamethasone followed by Linvoseltamab. The second approach continues with Daratumumab, Lenalidomide, and Dexamethasone throughout the treatment period.

Multiple Myeloma is a type of blood cancer that affects plasma cells, which are special white blood cells that help fight infections. The study aims to determine which treatment combination is more effective at eliminating cancer cells to a level that cannot be detected by very sensitive testing methods.

The medications used in this study are given in different ways. Lenalidomide is taken by mouth in capsule form, while Daratumumab and Linvoseltamab are given through an infusion into a vein. Dexamethasone can be given either as tablets by mouth or as an injection. The treatment continues for several weeks, and patients will need regular visits to the hospital for monitoring and receiving their medications.

1 Initial treatment phase

You will receive a combination of three medications: daratumumab (given by injection), lenalidomide (taken as capsules by mouth), and dexamethasone (taken as tablets by mouth)

This initial treatment will be provided to all study participants

2 Treatment assignment

You will be randomly assigned to one of two treatment groups

The assignment process is done by computer and cannot be chosen by you or your doctor

3 Continuation phase

Depending on your assigned group, you will either:

Continue with the same three-drug combination (daratumumab, lenalidomide, and dexamethasone)

Or switch to linvoseltamab (given by infusion into a vein)

4 Hospital stay requirement

If assigned to the linvoseltamab group, you will need to stay in or near the hospital (within 30 minutes) after receiving the first dose

5 Monitoring and testing

Regular blood tests will be performed to monitor your health

Bone marrow samples will be collected at various points during the study

Your disease status will be regularly evaluated through various tests

6 Study duration

The study is planned to run from September 2025 to October 2035

Your participation duration will depend on how your condition responds to treatment

Who Can Join the Study?

  • You must have a confirmed diagnosis of Multiple Myeloma with symptoms
  • You must be 18 years or older
  • You must be able to provide written informed consent to participate
  • You must be able to understand and complete study questionnaires
  • You must not be eligible for high-dose chemotherapy and stem cell transplant due to:
    – Advanced age, or
    – Significant health conditions that could affect treatment tolerance
  • You must have measurable disease levels through at least one of these tests:
    – Specific protein levels in blood of 1 g/dL or higher
    – Specific protein levels in 24-hour urine collection of 200 mg or higher
    – Certain blood protein chain levels of 10 mg/dL or higher
  • Your physical performance status must be rated as 0, 1, or 2 (able to perform most daily activities)
  • Your blood tests must show:
    – Adequate white blood cell counts
    – Hemoglobin levels of 7.5 g/dL or higher
    – Adequate platelet counts
    – Kidney function of 30 mL/min or better
    – Acceptable liver function tests
    – Controlled calcium levels
  • You must be willing to:
    – Attend clinic visits
    – Undergo bone marrow tests
    – Stay near the hospital (within 30 minutes) if assigned to the experimental treatment group
  • You must agree to follow pregnancy prevention guidelines if taking study medications

Who Cannot Join the Study?

  • Prior treatment for multiple myeloma (except for emergency use of local radiation therapy or a short course of corticosteroids)
  • Age under 18 years
  • Pregnant or breastfeeding women
  • History of other cancers within 3 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Severe heart conditions including heart failure (reduced heart’s ability to pump blood) or uncontrolled angina (chest pain)
  • Severe kidney problems requiring dialysis
  • Active, uncontrolled infections
  • Known HIV infection (human immunodeficiency virus)
  • Active hepatitis B or C infection (liver infections)
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 4 weeks before this study
  • Mental conditions that could interfere with following study procedures
  • Known allergies to any of the study medications
  • Inability to take oral medications
  • Life expectancy less than 6 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Region Oestergoetland Linkoping Sweden
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Universitario 12 De Octubre Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
University Hospital Limerick Limerick Ireland
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Ospedaliera di Padova Padua Italy
Fakultni Nemocnice Plzen Plzen Czechia
KBC Zagreb Zagreb Croatia
Evangelismos S.A. Athens Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Tartu University Hospital Tartu Estonia
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
University Hospital Galway Galway Ireland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Gasthuiszusters Antwerpen Antwerp Belgium
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Region Midtjylland Aarhus Denmark
University Hospital Olomouc Olomouc Czechia
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
CHU Helora La Louviere Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Region Sjaelland Holbæk Denmark
North Estonia Medical Centre Foundation Tallin Estonia
University Hospital Ostrava Ostrava Czechia
Beaumont Hospital Dublin Ireland
Sykehuset I Vestfold HF Tonsberg Norway
Uniklinikum Salzburg Salzburg Austria
Ouatvwruhvlobg Lhvx Gzja Linz Austria
Hrigynnv Udknqmnymjyfr Mqdghjg Dk Vkzbhxaonc Santander Spain
Cgrj Ucxkbrlnbu Hbfywotf Cork Ireland
Tfduvyuuev Cyuwyv Hyowmoxv Thessaloniki Greece
Azxvojw Owjjpwvttgc Oqouggct Rjjghwy Vbwmq Shgbf Cmgrgtzy Palermo Italy
Ivygfdrw Rqgjqlkli Pkf Lr Sbwzzr Dxg Tggmdu Djag Akyneui Iwiu Spcibg Meldola Italy
Hvttomgo Uxcdloscje Cmjbogn Hilgrohn Helsinki Finland
Exejvbu Ufpdpeuivnuy Moloecx Ccuijhb Rslqddajk (ssztzsh Mzl Rotterdam The Netherlands
Arduxfl Omcfjtxarxn Uphppgmrjuwgr Cglagwfeydua Dzogy Svqmej E Dpcnz Soemixd Dm Tzaupq Turin Italy
Azvfdpg Oysizznyapt Nolrlquan Sm Azqmjdp E Bacwil E C Aqixyg Ajprcewusjq Alexandria Italy
Uyltnrhdrxngpoxkzaquq Whbtenozh Afc Wuerzburg Germany
Acjlutq Uya Iosex Dy Rrkygt Egeuju Reggio Emilia Italy
Astbonj Ujigh Skrsuyccn Lbrlfi Dd Bwtgkfp Bologna Italy
Ueqsohpcvx Dxlwi Svlcb Dn Rwlz Lr Suroewzb Rome Italy
Imtpfdjp Cyhyjo Dvnnfmajymttfchxf L'hospitalet De Llobregat Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
29.09.2025
Belgium Belgium
Recruiting
29.09.2025
Croatia Croatia
Recruiting
29.09.2025
Czechia Czechia
Recruiting
29.09.2025
Denmark Denmark
Recruiting
29.09.2025
Estonia Estonia
Recruiting
29.09.2025
Finland Finland
Recruiting
29.09.2025
Germany Germany
Recruiting
29.09.2025
Greece Greece
Recruiting
29.09.2025
Ireland Ireland
Recruiting
29.09.2025
Italy Italy
Recruiting
29.09.2025
Norway Norway
Recruiting
29.09.2025
Portugal Portugal
Recruiting
29.09.2025
Spain Spain
Recruiting
29.09.2025
Sweden Sweden
Recruiting
29.09.2025
The Netherlands The Netherlands
Recruiting
29.09.2025

Trial locations

Daratumumab is a medication used to treat multiple myeloma. It works by targeting a specific protein on cancer cells, helping the immune system identify and destroy these cells.

Lenalidomide is a medication that helps fight multiple myeloma by strengthening the immune system and preventing the growth of cancer cells. It also works by blocking the blood supply to cancer cells.

Dexamethasone is a steroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often used in combination with other medications to enhance their effectiveness.

Linvoseltamab is an investigational medication being studied for the treatment of multiple myeloma. It is being tested as an alternative treatment option to compare its effectiveness with the standard treatment combination.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells interfere with the production of normal blood cells and can cause bone damage, leading to weakened bones. The disease also causes the overproduction of a single type of antibody, which can damage the kidneys and other organs. Multiple myeloma typically develops gradually and can affect various parts of the body, particularly the bones of the spine, skull, pelvis, rib cage, and hips.

Trial ID:
2024-519827-16-00
Protocol code:
EMN39
NCT ID:
NCT06932562
Trial Phase:
Therapeutic confirmatory (Phase III)

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