Study of elranatamab and lenalidomide combination versus standard chemotherapy and transplant in newly diagnosed multiple myeloma patients

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What is this study about?

This clinical trial focuses on treating patients with Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The study evaluates a treatment combination using elranatamab with lenalidomide and compares it to standard treatments. The medications used in the study include bortezomib, dexamethasone, daratumumab, and human normal immunoglobulin.

The purpose of this research is to determine if using elranatamab and lenalidomide together is more effective than current standard treatments for newly diagnosed multiple myeloma patients. The study is divided into two main phases: a consolidation phase, which follows initial treatment, and a maintenance phase, which aims to prevent the disease from returning.

During the study, patients will receive different combinations of medications through various methods, including oral capsules, tablets, and injections under the skin. Some medications will be given through an infusion into a vein. The treatment schedule will vary depending on which study group the patient is assigned to, and the total treatment period may last several months to years.

1 Initial treatment phase

Treatment begins with a combination of medications to target multiple myeloma

You will receive lenalidomide capsules taken by mouth

A bortezomib injection will be administered under the skin

Dexamethasone tablets will be taken orally

You will also receive normal immunoglobulin through an intravenous infusion

2 Consolidation phase

This phase includes two possible treatment paths:

Path 1: Combination of elranatamab and lenalidomide

Path 2: Standard chemotherapy followed by stem cell transplant

The treatment path will be determined randomly

Elranatamab is administered as an injection under the skin

Lenalidomide is taken as oral capsules

3 Maintenance phase

This phase also includes two possible treatment paths:

Path 1: Treatment with elranatamab injections under the skin

Path 2: Standard care treatment

The treatment path will be determined randomly

Regular assessments will monitor your response to treatment

Blood tests and medical examinations will be conducted throughout this phase

4 Follow-up period

Regular monitoring will continue to track your health status

Assessment of treatment effectiveness will be performed

Your overall health and quality of life will be evaluated

The study will continue until March 2036

Who Can Join the Study?

  • Age between 18 and 70 years old, both men and women can participate
  • Must have newly diagnosed multiple myeloma that qualifies for high-dose chemotherapy and stem cell transplantation
  • Must have at least 10% abnormal plasma cells in bone marrow OR have a confirmed tumor made up of plasma cells
  • Must have at least one of these signs:
    – High calcium levels in blood
    – Reduced kidney function
    – Low red blood cell count (anemia)
    – Bone damage visible on scans
    – High levels of abnormal proteins in blood or urine
  • Must have a performance status of 2 or better (able to perform most daily activities)
  • Must meet specific blood test requirements:
    – Adequate red blood cell levels
    – Adequate white blood cell counts
    – Normal liver function
    – Kidney function at least 40% of normal
    – Acceptable calcium levels
    – Adequate platelet counts
  • Must be willing and able to provide written informed consent
  • Women who can become pregnant must have a negative pregnancy test during screening and before starting treatment

Who Cannot Join the Study?

  • History of cancer other than Multiple Myeloma within the past 5 years, except for adequately treated skin cancers
  • Pregnant or breastfeeding women
  • Known active or chronic hepatitis B or C infection (inflammation of the liver caused by viruses)
  • Active, uncontrolled infections requiring treatment
  • Major surgery within 14 days before starting the study treatment
  • Serious heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable heart rhythm problems
    • Heart failure with symptoms
  • Severe kidney problems requiring dialysis
  • History of severe allergic reactions to similar treatments
  • Participation in other clinical trials within 30 days before starting this study
  • Mental conditions that could interfere with following study procedures
  • Any medical condition that the study doctor believes would make participation unsafe

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
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire De La Reunion St Denis France
Centre Hospitalier Blois Simone Veil Blois France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier William Morey Chalon Sur Saone France
Centre Hospitalier De Perpignan Perpignan France
Hopital D’Instruction Des Armees Percy Clamart France
Centre Hospitalier D Avignon Avignon France
Centre Henri Becquerel Rouen France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier De Bourg-En-Bresse Bourg En Bresse France
Centre Hospitalier Bretagne Atlantique Vannes France
Grand Hopital De L Est Francilien Meaux France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Universitaire De Rennes Rennes France
Institut De Cancerologie De Bourgogne Dijon France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Alexandra Lepeve Dunkirk France
Centre Hospital Region Metz Thionville Metz France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Centre Hospitalier Tarbes-Lourdes Tarbes France
Crnnus Lboj Beiwxg Lyon France
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Cpumld Hnyjwuyoeri Du Scjncmjovpht Saint-Brieuc France
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Cpxssh Hcqycxczkdx Em Udkipnyknkpsh Dc Lzzbciz Limoges France
Ciayjj Hesvkshnnul Uzegbggcbpnfy Dw Dufgm Dijon France
Beylgsdc Uuhlokhjbk Hgctcoju Cjfatn Besançon France
Cjobyt Hyjereapikw Rhtrwwtj Udzdlviznmaax Dq Tsttp Tours France
Coki Da Njsgx Vandoeuvre Les Nancy France
Cbrwci Htxubmkyyaf Reaqgoml Dkjmndotzzxjzu Angers France
Ittbednt dq Ctzsbddvcuxx Hpgdpblfnog Uaoxspzlaefeb dq Syvmg Ejwercu (cipltlw Saint Priest En Jarez France
Hebiyryj Unpqqmvedtzshc Stejfvfndb &fxqxti Hqruciq dr Hogiisgqxdt STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
15.03.2025

Trial locations

Elranatamab is a medication being studied for treating newly diagnosed multiple myeloma. It belongs to a class of drugs that help the immune system fight cancer cells. It is being tested as part of a combination therapy during the consolidation phase of treatment and as a maintenance therapy.

Lenalidomide is a medication commonly used to treat multiple myeloma. It works by helping to strengthen the immune system and can slow or stop the growth of cancer cells. In this trial, it is being studied in combination with elranatamab during the consolidation phase of treatment.

Autologous Stem Cell Transplant is a standard treatment procedure for multiple myeloma where the patient’s own healthy blood-forming stem cells are collected and later reinfused after receiving high-dose chemotherapy. This trial is evaluating whether the combination of elranatamab and lenalidomide could potentially replace this procedure.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that produce antibodies. The condition occurs when abnormal plasma cells multiply rapidly in the bone marrow, crowding out healthy blood cells and producing faulty antibodies called M proteins. These abnormal cells can cause several issues throughout the body, particularly in the bones, which can become weak and prone to problems. Over time, the disease can affect multiple body systems, including the bones, blood, kidneys, and immune system. The disease typically develops gradually, and some people may not experience symptoms in early stages.

Trial ID:
2024-516418-39-00
Protocol code:
IFM2025-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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