Study Comparing Elranatamab and Lenalidomide with Daratumumab and Lenalidomide for Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients

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What is this study about?

This clinical trial is focused on studying a disease called multiple myeloma, which is a type of cancer that affects the blood cells in the bone marrow. The study is testing two different treatment combinations to see which is more effective as a maintenance therapy after a patient has undergone a transplant. The first combination includes the medications elranatamab and lenalidomide, while the second combination includes daratumumab and lenalidomide. Elranatamab is given as an injection under the skin, while lenalidomide is taken as a capsule by mouth. Daratumumab is also given as an injection under the skin.

The purpose of the study is to compare the effectiveness of these two treatment combinations in helping patients maintain their health after a transplant. Participants in the study will receive one of the two treatment combinations and will be monitored over a period of time to see how well the treatments work. The study will look at various outcomes, such as how long patients remain free of disease progression and their overall survival rates.

Throughout the study, participants will have regular check-ups and assessments to monitor their health and the effects of the treatment. The study aims to provide valuable information on which treatment combination might offer better support for patients with newly diagnosed multiple myeloma after they have received a transplant. This research could help improve future treatment options for people with this condition.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive a combination of elranatamab and lenalidomide or a combination of daratumumab and lenalidomide as part of your treatment.

2 treatment administration

If you are in the elranatamab and lenalidomide group, you will receive elranatamab through an injection under the skin (subcutaneous use) and lenalidomide orally (by mouth).

If you are in the daratumumab and lenalidomide group, you will receive daratumumab through an injection under the skin (subcutaneous use) and lenalidomide orally (by mouth).

3 treatment schedule

The treatment will be administered in cycles. Each cycle lasts for a specific period, and you will receive the medications according to the schedule provided by the study team.

The study aims to compare the effectiveness of the two treatment combinations over a period of 12 cycles, with assessments at various points to monitor your response to the treatment.

4 monitoring and assessments

Throughout the study, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. This includes blood tests and other evaluations as required by the study protocol.

The primary goal is to determine the rate of minimal residual disease (MRD) negativity, which indicates the absence of detectable cancer cells after treatment.

5 end of treatment

After completing 12 cycles of treatment, further assessments will be conducted to evaluate the long-term effects and benefits of the treatment.

You will continue to be monitored for any changes in your condition, and additional follow-up may be required as part of the study’s objectives.

Who Can Join the Study?

Participants must be male or female and 18 years of age or older.
Men must agree not to father a child and use a latex condom during the study and for 6 months after the last dose of the study drug, even if they have had a successful vasectomy, if their partner can become pregnant.
Participants must provide voluntary written informed consent before any study-related procedures that are not part of normal medical care. They can withdraw consent at any time without affecting future medical care.
Participants must have documented multiple myeloma according to specific criteria and have received 4 to 6 cycles of a specific therapy that includes a proteasome inhibitor, IMID (a type of drug), and anti CD38 monoclonal antibody (a type of protein used in treatment).
Participants must have received only one line of therapy and achieved at least a partial response according to specific criteria.
Participants must have received high-dose melphalan (a chemotherapy drug) and ASCT (a type of stem cell transplant) within 12 months of starting initial therapy and be within 6 months of the last ASCT at the time of the first treatment dose.
Participants must have had NGS analysis (a type of genetic testing) performed at the time of multiple myeloma diagnosis or have adequate stored bone marrow material for this analysis.
Participants must have a Karnofsky performance status score of 50% or higher, which is a way to measure their ability to perform daily activities.
Participants must have certain clinical laboratory values during the screening phase, including:
- Hemoglobin greater than 8.0 g/dL without a recent red blood cell transfusion.
- Platelets 75 x 10⁹/L or higher without recent transfusion support.
- Absolute neutrophil count 1.0 x 10⁹/L or higher without recent growth factor support.
- AST and ALT levels 2.5 times the upper limit of normal or lower.
- Creatinine clearance 30 mL/min or higher, which measures kidney function.
- Total bilirubin 1.5 times the upper limit of normal or lower, except in certain conditions.
- Serum calcium corrected for albumin 14 mg/dL or lower.
Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use two methods of birth control or remain abstinent from heterosexual intercourse, starting at least 4 weeks before treatment and continuing for at least 6 months after the last dose of the study drug. They must also agree to report any pregnancy during the study.

Who Cannot Join the Study?

Patients who have not had a stem cell transplant cannot participate. A stem cell transplant is a procedure where healthy blood-forming cells are given to replace damaged or diseased bone marrow.
Patients who have not been diagnosed with multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow.
Patients who are under 18 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have any other serious medical conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hopital Necker Enfants Malades	Paris	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier De Perpignan	Perpignan	France
Hopital D’Instruction Des Armees Percy	Clamart	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier De Perigueux	Perigueux	France
Groupe Hospitalier Bretagne Sud	Lorient	France
Centre Hospitalier Intercommunal Compiegne Noyon	Compiegne	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Institut De Cancerologie De Bourgogne	Dijon	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Groupe Hospitalier Rance Emeraude	Saint-Malo	France
Centre Hospitalier Saint Nazaire	St Nazaire	France
Centre Hospitalier Tarbes-Lourdes	Tarbes	France
Cwnmzw Lrcn Bkbfev	Lyon	France
Ckjysj Hjpmxmtfvxe Rlctwwhj Duoppapqqayjre	Angers	France
Csj dpniouvignjiqm	Epagny Metz Tessy	France
Cacmhl Hutwbinacgz Ec Uygdnserhkasf Dh Lzzywrh	Limoges	France
Ccpezd Hpoouwlxzki Uirvxanalybju Ds Dbomr	Dijon	France
Aaigvimebb Pymyfesf Hbuobkaf Dy Ppfzt	Paris	France
Aqrpwtxzjr Pvbpgzxn Hkqjqbkh Di Muqgzwvtj	Marseille	France
Biupzmcx Uslcpbolyl Hrnglgbq Cfsioc	Besançon	France
Cljvou Htgbeycakkt Rhpzhpmo Uywigtzzvdlft Dw Tbrdf	Tours	France
Ckub Dx Nblff	Vandoeuvre Les Nancy	France
Hwscttv Hohew Mmslto &oxuoza 1 rrz Gdaplvm Ekiqir	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Elranatamab is a medication being studied for its potential to help patients with newly-diagnosed myeloma. It is used in combination with another medication to see if it can improve the outcomes for patients who have undergone a transplant. Elranatamab works by targeting specific cells in the body that are involved in the disease, aiming to reduce their activity and help control the condition.

Lenalidomide is a medication that is often used in the treatment of myeloma. It helps the immune system fight cancer cells and can also stop the growth of new blood vessels that tumors need to grow. In this study, lenalidomide is used alongside other medications to see if it can improve the effectiveness of the treatment after a transplant.

Daratumumab is another medication used in the treatment of myeloma. It is an antibody that targets a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells. In this trial, daratumumab is combined with lenalidomide to evaluate its effectiveness as a maintenance therapy after a transplant.

Investigated diseases:

Plasma cell myeloma

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, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. These proteins can cause damage to bones and other organs, such as the kidneys. As the disease progresses, it can lead to bone pain, fractures, and anemia due to the overcrowding of healthy blood cells. Patients may also experience increased susceptibility to infections. Over time, the accumulation of abnormal cells and proteins can disrupt normal bodily functions.

Trial ID:

2024-517325-43-00

Protocol code:

RC23_0603

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Elranatamab and Lenalidomide with Daratumumab and Lenalidomide for Maintenance Therapy in Newly Diagnosed Multiple Myeloma Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?