#1 Clinical Trials Search in Europe

Study Comparing Elranatamab and Lenalidomide for Patients with Newly Diagnosed Multiple Myeloma After Stem-Cell Transplantation

3 1 1 1

What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is comparing two treatments for patients who have been newly diagnosed with this condition and have undergone a procedure called autologous stem-cell transplantation, which involves using the patient’s own stem cells to help restore bone marrow. The treatments being compared are Elranatamab, also known by its code name PF-06863135, and Lenalidomide, which is available in different dosages under the brand name Zelvina.

The purpose of the study is to evaluate how effective Elranatamab is compared to Lenalidomide in treating patients with Multiple Myeloma. Participants in the study will be randomly assigned to receive either Elranatamab or Lenalidomide. Elranatamab is administered as a solution for injection under the skin, while Lenalidomide is taken orally in capsule form. The study will monitor the participants over a period of time to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will have regular check-ups and tests to track their health and the progress of their Multiple Myeloma. The main goal is to determine which treatment helps patients live longer without their disease getting worse. This information will help doctors make better treatment decisions for future patients with Multiple Myeloma.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives elranatamab, and the other group receives lenalidomide.

2 elranatamab administration

Participants in the elranatamab group receive the medication through a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

3 lenalidomide administration

Participants in the lenalidomide group take the medication orally. The study uses Zelvina capsules, available in 15 mg, 5 mg, and 10 mg doses. The exact dosage and frequency are specified in the study protocol.

4 additional treatments

Some participants may receive human normal immunoglobulin through an IV infusion as part of their treatment plan. This is administered as Privigen 100 mg/ml solution for infusion.

5 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments to evaluate their health and the effectiveness of the treatment. This includes laboratory tests and other procedures as outlined in the study protocol.

6 study duration

The study is expected to continue until October 31, 2029. Participants remain in the study for the duration specified in the protocol, unless they choose to withdraw or are advised to stop for medical reasons.

Who Can Join the Study?

  • Participants must be at least 18 years old, or the minimum age of consent in their country if it’s higher than 18.
  • Both male and female participants of childbearing potential must agree to use birth control.
  • Participants should be willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
  • Participants must have a diagnosis of Multiple Myeloma with measurable disease, as defined by specific criteria involving blood and urine tests.
  • Participants should have achieved a partial response or better to previous treatment, according to specific criteria.
  • The main cancerous cell type must be identified through a specific laboratory test.
  • Participants should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The heart’s ability to pump blood, measured as left ventricular ejection fraction, should be at least 40%.
  • Liver function should be adequate, with specific limits on liver enzymes and bilirubin levels.
  • Kidney function should be adequate, with a specific measure of how well the kidneys filter blood.
  • Participants must have recovered from any previous treatments, with blood cell counts and hemoglobin levels meeting specific criteria.
  • Calcium levels in the blood should be within a certain range.
  • Participants must be able to understand and sign a consent form, agreeing to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients who have a serious heart condition, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a condition that affects their immune system, like HIV or AIDS.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have a mental health condition that might affect their ability to participate in the study.
  • Patients who have received certain treatments for multiple myeloma in the past.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Poliklinik gGmbH Chemnitz Chemnitz Germany
Medical University Of Vienna Vienna Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Hopital Saint Antoine Paris France
Hopitaux Universitaires Pitie Salpetriere Paris France
Institut Jules Bordet Anderlecht Belgium
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
Region Oestergoetland Linkoping Sweden
Region Oerebro Laen Orebro Sweden
Isala Klinieken Stichting Zwolle The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Helse Stavanger HF Stavanger Norway
Grand Hopital De Charleroi Charleroi Belgium
Region Skane Helsingborg Hospital Helsingborg Sweden
Oulu University Hospital Oulu Finland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Region Dalarna Falun Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Pratia Hematologia Sp. z o.o. Katowice Poland
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
University General Hospital Of Ioannina Ioannina Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Turku University Hospital Turku Finland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Gasthuiszusters Antwerpen Antwerp Belgium
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Universitair Ziekenhuis Gent Gent Belgium
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
University Hospital Ostrava Ostrava Czechia
Universitaetsklinikum Leipzig AöR Leipzig Germany
Ubnxozbbiiqlnmscxbizc Eahpe Agu Essen Germany
Upfmhuxixx Dunlp Siivn Do Rkvy Lq Swlkncie Rome Italy
Hkgcxlbr Usgkfzqywvnui Di Lb Palynegu Madrid Spain
Ilddcdvl Cqcxxb Dtksptnnhqiiqogsp L'hospitalet De Llobregat Spain
Tvrxphupdw Crufbf Hqotycbs Thessaloniki Greece
Iifkypgy Rmhirozed Ppo Lq Ssyhsm Dgs Tllqhf Demf Avgpcqa Inbj Slxpne Meldola Italy
Hfezckhv Uegnczlirt Cvdfiah Hxpesptu Helsinki Finland
Anqczdn Oxhxobuwjjl Unqminyvxgpoy Sjwpip Siena Italy
Cbbipc Hifdweibduv Rdevbylc Usdxwxdqgrcqi Dz Tujsp Tours France
Nsactcbg Iekimaii Okbsobdvc Icu Mclbd Swjdtmbdcscvyjjlbegpiotnueqc Ifegojjw Bcdvkeeb Cracow Poland
Uwrutgbuepjwuljmhfjow Wpknnuian Afp Wuerzburg Germany
Aylvfwa Udxvf Sahnkyhqx Lvqrir Dq Beocqtx Bologna Italy
Uyrievonlbhiyn Cwgleit Kxbvrqrqk Gdansk Poland
Fhmagiqyd Pcfz Lk Ipoohvbqzxrvz Byjtdyblz Dfr Hsaobntl Uucsmtlhcosxe La Ptt Madrid Spain
Hcjdjdov Ukdrbbodquuia Hchltzse Tbhew y Pttjgb Ipbnusdo Ctgzzp drhxktwvgstnylxed (lutr Badalona Spain
Hokpdixq Vjbq dctlrvab Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
28.04.2022
Belgium Belgium
Not recruiting
28.04.2022
Czechia Czechia
Not recruiting
28.04.2022
Finland Finland
Not recruiting
28.04.2022
France France
Not recruiting
28.04.2022
Germany Germany
Not recruiting
28.04.2022
Greece Greece
Not recruiting
28.04.2022
Hungary Hungary
Not recruiting
28.04.2022
Italy Italy
Not recruiting
28.04.2022
Norway Norway
Not recruiting
28.04.2022
Poland Poland
Not recruiting
28.04.2022
Spain Spain
Not recruiting
28.04.2022
Sweden Sweden
Not recruiting
28.04.2022
The Netherlands The Netherlands
Not recruiting
28.04.2022

Trial locations

Investigated drugs:

Elranatamab is a medication being studied for its effectiveness in treating patients with newly diagnosed multiple myeloma. It is being compared to another treatment to see how well it works in patients who have already undergone a stem-cell transplant. Elranatamab is designed to help the immune system target and destroy cancer cells.

Lenalidomide is a medication used in the treatment of multiple myeloma. It works by affecting the immune system to help slow down or stop the growth of cancer cells. In this study, lenalidomide is being used as a comparison to evaluate the effectiveness of elranatamab in patients who have had a stem-cell transplant.

Investigated diseases:

Multiple Myeloma – Multiple Myeloma 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 disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the reduced production of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time.

Trial ID:
2023-508897-27-00
Protocol code:
C1071007
NCT ID:
NCT05317416
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

    Recruiting

    4 1 1 1
    Investigated drugs:
    France Norway Spain

  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

    Recruiting

    1 1 1 1
    Investigated drugs:
    Norway