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Active not recruitingPHASE2INTERVENTIONAL

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

This clinical trial is for people aged 18 to 65 who have recently been diagnosed with multiple myeloma and are planning for a stem cell transplant. It's a 'Phase 2' study, which means it's testing whether new drug combinations are safe and effective. Participants will first receive a standard treatment (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone). After this, their cancer will be checked very closely for any remaining disease, called 'minimal residual disease' (MRD). Depending on these results, participants will then receive one of two new treatment combinations: either teclistamab with lenalidomide, or teclistamab with talquetamab. The aim is to see if these personalised approaches can further improve outcomes for patients, helping to keep the cancer under control.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Nantes University Hospital
Enrolment target
103
Start
26 Jun 2024
Estimated completion
26 Jun 2030

What is this study about?

This study is investigating new ways to treat multiple myeloma in people who are diagnosed recently and are suitable for a stem cell transplant. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. The study is called a 'Phase 2' trial, meaning it's exploring whether certain drug combinations are safe and work well, after initial testing has shown promise.

First, everyone in the study will receive a standard, well-known treatment called D-VRd (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone). After this initial treatment, doctors will perform very sensitive tests to see if there are any tiny traces of cancer cells left. This is called 'minimal residual disease' or MRD. The results of this special test will help decide the next step in treatment.

Depending on whether MRD is detected, participants will then be put into one of two groups. One group will receive teclistamab teamed up with lenalidomide, while the other group will get teclistamab combined with talquetamab. These drugs are designed to help the body's immune system fight the cancer. The researchers want to see if tailoring the treatment based on the MRD results can lead to better long-term control of multiple myeloma.

Key takeaways

  • This study explores personalised treatment for newly diagnosed multiple myeloma.
  • It uses standard treatment first, followed by new drug combinations based on remaining cancer cells (MRD).
  • New drugs being tested include teclistamab and talquetamab, which boost your immune system.
  • It's for people aged 18 to 65 who are eligible for a stem cell transplant.
  • You'll have close monitoring and regular check-ups if you participate.

Who may be eligible?

This study is looking for men and women who are newly diagnosed with multiple myeloma. You need to be between 18 and 65 years old. Your multiple myeloma must meet certain criteria, which your doctor will be able to explain, and it needs to be the kind that can be measured.

You also need to be well enough to take part. This means your general health and fitness, measured by something called a 'performance status' score, must be at a certain level. Your blood and other lab test results should also be within a specific range.

If you are a woman who could become pregnant, you'll need to have negative pregnancy tests and use two reliable forms of contraception. Men also have specific requirements about contraception. It's important to discuss all these details with your doctor to see if this study could be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 65 years old?
  2. Have you been newly diagnosed with multiple myeloma?
  3. Is your doctor considering you for a stem cell transplant?
  4. Are you generally well enough for treatment, with good fitness levels?
  5. If you are a woman who could become pregnant, are you able to use two reliable birth control methods?
Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive a standard course of treatment called D-VRd. After this, tests will be done to check for any remaining cancer cells (minimal residual disease). Depending on these results, you will then receive one of the new drug combinations (either teclistamab with lenalidomide, or teclistamab with talquetamab).

Participation usually involves regular visits to the clinic for medical check-ups, blood tests, and to receive your study medications. The frequency and length of these visits will depend on the specific treatment phase you are in. You will be closely monitored throughout the study for any side effects and to see how well the treatment is working. After the main treatment period, there will be follow-up appointments to track your health over time. The total duration of your participation will be fully explained by the study team.

Potential risks and benefits

Taking part in this study could offer the potential benefit of receiving new and promising treatments for multiple myeloma, which might help control your disease more effectively than standard approaches alone. However, like all medications, the new treatments being tested can have side effects, and some may be serious. The research team will carefully monitor you for any reactions and manage them as best as possible. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

  • CH de la Côte Basque
    Verified postcode
    Bayonne, France
  • CHU Caen
    Verified postcode
    Caen, France
  • CHRU DIjon
    Verified postcode
    Dijon, France
  • Chd Vendee
    Verified postcode
    La Roche-sur-Yon, France
  • CHRU LILLE - Hôpital Claude Huriez
    Verified postcode
    Lille, France
  • CHU Limoges
    Verified postcode
    Limoges, France
  • CH Lyon Sud
    Verified postcode
    Lyon, France
  • IPC Marseille Institut Paoli Calmettes
    Verified postcode
    Marseille, France
  • CHU Montpellier
    Verified postcode
    Montpellier, France
  • CHU de Nantes
    Verified postcode
    Nantes, France
  • APHP Hôpital Saint-Antoine
    Verified postcode
    Paris, France
  • APHP Hôpital La Pitié Salpétrière
    Verified postcode
    Paris, France

Common questions

What is 'minimal residual disease' (MRD)?

MRD refers to tiny amounts of cancer cells that can remain in your body after treatment, even if scans don't show them. Special tests are used to find these cells.

What is a 'Phase 2' study?

A Phase 2 study is a stage in drug development where researchers test new treatments on a larger group of people to see if they are safe and effective for a specific health condition.

What are teclistamab and talquetamab?

These are newer types of drugs called 'T-cell redirectors'. They work by helping your body's own immune system (T-cells) find and attack cancer cells.

Will I know which treatment combination I'm getting?

Yes, once your minimal residual disease status is determined after the initial treatment, you will be assigned to a specific treatment combination, and you will know which one you are receiving.

How long will the study last for me?

The exact length of your participation will be discussed in detail by the study team. It involves treatment periods and follow-up, which can last for a significant time.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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