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

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What is this study about?

This study is being conducted to evaluate the effectiveness and safety of a new treatment for people with newly diagnosed Multiple Myeloma. Multiple Myeloma is a type of blood cancer that develops in the plasma cells, which are a type of white blood cell. This specific study focuses on individuals who are not eligible to receive a bone marrow transplant as part of their treatment.

Participants in the study will be assigned to receive different combinations of medications. One group will receive Etentamig, which is given as an intravenous infusion, alongside Daratumumab. The other group will receive a combination of Daratumumab, Lenalidomide, and Dexamethasone. Dexamethasone is a type of steroid used to reduce inflammation, and Lenalidomide is an oral medication often used to treat cancer.

The study is divided into two main parts. The first part aims to find the correct amount of Etentamig to use when combined with Daratumumab. The second part compares the effectiveness of the Etentamig and Daratumumab combination against the standard treatment of Daratumumab, Lenalidomide, and Dexamethasone. During the study, participants will be monitored to see how the treatments affect the disease and to track any side effects.

Who Can Join the Study?

You must have a confirmed diagnosis of newly diagnosed multiple myeloma, which is a type of blood cancer that affects plasma cells in your bone marrow.
You must not be able to undergo high-dose chemotherapy or a stem cell transplant (a procedure where healthy blood-forming cells are put back into the body) because of health factors that might make these treatments too hard for your body to handle.
Your myeloma frailty index score, which is a tool used by doctors to measure how much a person’s health is affected by their cancer, must be 1 or higher.
Your ECOG performance status, which is a scale used to measure how well you can perform everyday activities, must be 1 or lower, meaning you are mostly active and able to carry out light work.
Your cancer must be measurable through laboratory tests conducted within 28 days before joining the study.
To be considered measurable, you must have one of the following: a specific level of M-protein (an abnormal protein produced by cancer cells) in your blood, a specific level of M-protein in your urine, or an abnormal level of free light chains (small proteins produced by plasma cells) in your blood.

Who Cannot Join the Study?

You cannot participate if you have already received or are currently receiving systemic therapy (treatment that travels through your whole body, such as drugs) or SCT (stem cell transplant) for multiple myeloma or other conditions involving abnormal plasma cells (a type of white blood cell), unless you only took a short course of corticosteroids (a type of steroid medicine used to reduce swelling or inflammation).
You cannot participate if you have received anti-cancer therapy, such as chemotherapy (drugs used to kill cancer cells), radiotherapy (using radiation to treat cancer), biologics (medicines made from living organisms), immunotherapy (treatment that helps your immune system fight cancer), or cellular therapies (treatments using living cells), or if you took high doses of steroids (medicine to reduce inflammation), within 21 days before starting the study.
You cannot participate if you have had a major surgical procedure (a large operation) within 21 days before the first dose of the study treatment.
You cannot participate if you have used an investigational treatment (a medicine being tested in a study) within 30 days before starting the study.
You cannot participate if you are currently enrolled in another clinical study (a research test to see if a new treatment works).
You cannot participate if your multiple myeloma is known to be active in the central nervous system (the part of your body that includes your brain and spinal cord).
You cannot participate if you have a history in the last 6 months of serious diseases involving your renal (kidney) system, neurologic (brain or nerve) system, psychiatric (mental health) system, endocrine (hormone) system, metabolic (how your body uses energy) system, immunologic (immune system) system, pulmonary (lung) system, or hepatic (liver) system, if your doctor believes these conditions would make participating in the study unsafe or difficult.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Leon	Leon	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Bretagne Atlantique	Vannes	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
Hzcxvvks Uvovfzlignvlt Mfqrxin Dn Vpdluuzwwv	Santander	Spain
Cwl dgvfuquvsdlclh	Epagny Metz Tessy	France
Cixerw Hmduyhhmaia Rzrtixmw Uqfzifdwbcabe Dn Tukhz	Tours	France
Ixhzlgse Cjtqky Dsderjtovnujpyyvk	L'hospitalet De Llobregat	Spain
Iosrlfnw dy Cmcdmlmqtchd Hasikjwdwsd Uqpalypivnvxd dt Sjylv Epalumt (qecjkua	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.06.2026
Norway	Not yet recruiting	30.06.2026
Spain	Recruiting	30.06.2026

Trial locations

Investigated drugs:

Etentamig is the experimental medication being studied in this trial. It is given as an infusion through a vein and is being tested alongside another medication to see how well it works in treating newly diagnosed multiple myeloma in patients who are not able to undergo a stem cell transplant.

Daratumumab is a medication used in this study both on its own and in combination with the experimental drug. It is administered as an injection under the skin to help target and fight the cancer cells.

Lenalidomide is a medication used in the comparison group of this study. It is taken by mouth and helps to treat multiple myeloma by affecting the immune system and the growth of cancer cells.

Dexamethasone is a type of steroid medication used in this study. It can be taken orally or given through an injection into a vein to help treat the cancer and reduce inflammation.

Multiple Myeloma – This is a type of cancer that begins in the plasma cells, which are a type of white blood cell. These abnormal cells accumulate in the bone marrow and can crowd out healthy blood cells. As the disease progresses, the cancerous cells produce abnormal proteins that can interfere with normal body functions. This condition often leads to changes in the bone structure and can affect the kidneys. Over time, the uncontrolled growth of these cells continues to impact various bodily systems.

Trial ID:

2025-520897-21-00

Protocol code:

M25-586

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?