Study of daratumumab, teclistamab and talquetamab combination treatment for frail patients with newly diagnosed multiple myeloma

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What is this study about?

This clinical trial focuses on patients with Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study investigates a combination treatment approach using three medications: daratumumab, teclistamab, and talquetamab. These medications are given as solutions for injection under the skin (subcutaneous injection).

The main purpose of this research is to evaluate how well patients respond to treatment over an 18-month period. The study specifically targets newly diagnosed patients who have not received any previous treatment and are considered frail according to medical assessment criteria. Patients will be divided into two groups – one receiving daratumumab with teclistamab, and the other receiving daratumumab with talquetamab.

During the study, patients will receive their assigned combination of medications through injections under the skin. The treatment will continue while monitoring how well the cancer responds and checking for any side effects. The medications work by helping the body’s immune system fight against the cancer cells. Regular medical check-ups and tests will be performed to track the progress of the treatment.

1 Initial treatment phase

You will receive a combination of medications through subcutaneous injections (injections under the skin).

Depending on your assigned group, you will receive either Teclistamab with Daratumumab (Group 1) or Talquetamab with Daratumumab (Group 2).

Regular blood tests will be performed to monitor your condition and measure the response to treatment.

Your doctor will monitor for any side effects during the treatment period.

2 Disease monitoring

Your condition will be regularly assessed to check how well the treatment is working.

The main assessment will occur at 18 months after starting treatment.

Tests will include measuring the levels of M-protein (a protein produced by myeloma cells) in your blood.

Additional tests will be performed to check for signs of minimal residual disease (MRD), which means looking for any remaining cancer cells.

3 Follow-up period

After completing the initial treatment, you will continue to be monitored for any changes in your condition.

Regular assessments will track how long the treatment effects last.

If needed, additional treatment may be considered based on your response to the initial therapy.

The total study duration is planned until February 2034.

4 Safety monitoring

Throughout the study, you will be monitored for any side effects or complications.

Special attention will be paid to tracking any infections that may occur.

Blood tests will be regularly performed to check your overall health status.

Any treatment-related issues will be documented and addressed by your healthcare team.

Who Can Join the Study?

  • Must be 18 years or older
  • Must be able to understand and sign an informed consent form showing willingness to participate in the study
  • Must be newly diagnosed with Multiple Myeloma and have not received any previous treatment
  • Must have measurable disease, which means either:
    • A specific protein (M-protein) level in blood of 1 g/dL or higher, or
    • A specific type of protein (free light chain) level of 10 mg/dL or higher with abnormal protein ratios in blood
  • Must be classified as frail according to specific medical criteria
  • Must meet specific laboratory test requirements
  • If able to have children, must agree to use effective birth control methods during the study and for 3 months after the last dose of study medication

Who Cannot Join the Study?

  • Prior treatment for multiple myeloma (a type of blood cancer affecting plasma cells)
  • History of cancer within the past 5 years, except for successfully treated non-melanoma skin cancer
  • Known allergies or severe reactions to the study medications or their components
  • Serious heart conditions, including:
    • Heart failure requiring treatment
    • Uncontrolled high blood pressure
    • Unstable heart rhythm problems
  • Active or chronic infections, including:
    • Hepatitis B (liver infection)
    • Hepatitis C (liver infection)
    • HIV (human immunodeficiency virus)
  • Severe kidney problems requiring dialysis
  • Severe liver problems
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that could interfere with following study procedures
  • Any condition that, in the opinion of the study doctor, 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
Oslo Universitetssykehus HF Oslo Norway
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Azienda Sanitaria Locale Di Pescara Pescara Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Central Hospital Of Bolzano Bolzano Italy
St. Antonius Ziekenhuis Nieuwegein The Netherlands
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno Ascoli Piceno Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Sykehuset I Vestfold HF Tonsberg Norway
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Rvxycoxok Ztgquwccas Scxpmcsxb Arnhem The Netherlands
Uqhvnhsjykxf Mztuomo Cldtrai Gqsrhawir Groningen The Netherlands
Ciyjhcywmmotl Dpeow Sdmyq Ijlacwtvdd Dxztoikjeuivemnkdpzwy Como Italy
Asfxovy Sezymnhan Lbphdb Retc 1 Rome Italy
Ajwkziqrg Ukj Amsterdam The Netherlands
Aznyeyf Ocmazaickht Uxhaldoborfvb Ciwkxdnqyngh Djxoc Sgbwbl E Djbls Svikvnd Ds Tcikhw Turin Italy
Apgejxr Uvlcr Sqdxbrhgu Lttgyx Dr Blkeycv Bologna Italy
Arsipnb Oavjzzfdvmp Pnse Gvmtlyao Xvidf Bergamo Italy
Usylejzklb Dvbsv Sfhzd Du Rvmv Lg Skuphasx Rome Italy
Hplrkiic Voss djddynzn Barcelona Spain

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
03.11.2025
Norway Norway
Not yet recruiting
03.11.2025
Spain Spain
Not yet recruiting
03.11.2025
The Netherlands The Netherlands
Recruiting
03.11.2025

Trial locations

Teclistamab is a medication used to treat multiple myeloma, a type of blood cancer. It works by helping your immune system recognize and fight cancer cells. This medication is designed to target specific proteins found on cancer cells, making it a targeted therapy.

Talquetamab is also a treatment for multiple myeloma. Like teclistamab, it works by engaging your immune system to fight cancer cells. It targets different proteins on the surface of cancer cells to help destroy them.

Daratumumab (often called Dara) is an antibody therapy used in treating multiple myeloma. It works by targeting a specific protein found on myeloma cells, helping the immune system identify and destroy these cancer cells. It’s commonly used in combination with other treatments to improve their effectiveness.

Multiple Myeloma – A blood cancer that develops in plasma cells, which are white blood cells that help fight infection. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies, called M proteins, which can cause various complications. The disease often affects multiple bones in the body, leading to weakened bones and potential fractures. Multiple myeloma typically develops gradually, starting from a precancerous condition called monoclonal gammopathy of undetermined significance (MGUS). The disease can cause various symptoms including bone pain, frequent infections, fatigue, and kidney problems.

Trial ID:
2024-520433-76-00
Protocol code:
EMN37
Trial Phase:
Therapeutic exploratory (Phase II)

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