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Active not recruitingPHASE3INTERVENTIONAL

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

This research study is looking at a new combination of medicines called teclistamab and daratumumab, known as Tec-Dara. We want to see if Tec-Dara is more effective than current standard treatments for people with multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow and has either returned after previous treatment or isn't responding to existing therapies. The standard treatments being compared are daratumumab combined with either pomalidomide and dexamethasone (DPd), or bortezomib and dexamethasone (DVd). The main goal is to find out which treatment works best to control the cancer and improve patient outcomes.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
587
Start
14 Oct 2021
Estimated completion
08 Dec 2028

What is this study about?

This clinical trial is designed to investigate a new treatment approach for multiple myeloma, a cancer of the blood plasma cells. If you or someone you know has multiple myeloma, you might be familiar with how challenging it can be when the disease comes back or doesn't respond well to initial treatments. This study is focusing on patients in that situation, aiming to offer a potentially more effective option.

The trial will compare a new combination of medicines, known as Tec-Dara (teclistamab with daratumumab), against two established treatment combinations: DPd (daratumumab, pomalidomide, and dexamethasone) and DVd (daratumumab, bortezomib, and dexamethasone). The hope is to demonstrate that Tec-Dara can improve how well patients respond to treatment and potentially extend the time before the cancer progresses again. This is a crucial step in finding better ways to manage multiple myeloma for those who need more options.

By carefully comparing these treatments, researchers want to understand which one is more effective at fighting the disease. The results from this study will be incredibly important in helping doctors decide the best course of action for patients whose multiple myeloma has returned or is hard to treat. This kind of research is vital for advancing medical science and improving the lives of people living with multiple myeloma.

Key takeaways

  • Compares a new combination treatment (Tec-Dara) for multiple myeloma.
  • Aimed at patients whose myeloma has returned or isn't responding well.
  • Tests if Tec-Dara is more effective than standard treatments.
  • Participation involves receiving one of the study treatments and regular health checks.
  • Potential for a new effective treatment option.
  • Involves regular monitoring for safety and effectiveness.

Who may be eligible?

To be considered for this study, you would need to have a confirmed diagnosis of multiple myeloma, and your disease must be measurable, meaning we can track its presence in your blood or urine. You should have already received between one and three previous lines of treatment for your myeloma, including a medicine called a proteasome inhibitor and lenalidomide. If you've only had one previous treatment, it must be clear that your myeloma didn't respond or got worse while on lenalidomide, or within 60 days of stopping it. Your disease must also show signs of progression after your last treatment.

There are also some general health requirements, including having a good enough physical condition to participate in the study, as determined by a standard rating system (ECOG performance status of 0, 1, or 2). Your blood test results and other health checks would need to fall within specific healthy ranges to ensure your safety throughout the trial.

However, some conditions would prevent you from joining. For example, if you have any severe allergies or reactions to any of the study medications, you wouldn't be able to participate. Also, if your myeloma has already been shown to be resistant to pomalidomide, you wouldn't be able to receive the DPd treatment arm meant for comparison. Similar restrictions apply if you are unable to receive the DVd treatment arm.

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. Have you been diagnosed with multiple myeloma?
  2. Has your multiple myeloma come back or stopped responding to previous treatments?
  3. Have you had 1 to 3 previous lines of myeloma treatment, including lenalidomide and a proteasome inhibitor?
  4. Are you generally well enough to participate in a clinical study (ECOG 0-2)?
  5. Are you free from severe allergies to the study medications?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to receive either the new combination treatment (Tec-Dara) or one of the standard comparison treatments (DPd or DVd). This is done randomly, like flipping a coin, so neither you nor your doctor can choose which treatment you get. You will receive your treatment through injections under the skin (subcutaneously) and possibly other ways, depending on the specific medicines and your assigned group. You'll have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. The total duration of your participation will depend on various factors, including how well you respond to treatment and your overall health, and will involve ongoing follow-up visits.

Potential risks and benefits

Participating in this study might offer the benefit of accessing a new treatment combination that could potentially be more effective for your multiple myeloma than existing options, helping to control your disease and improve your quality of life. However, like all medications, the treatments in this study can have side effects, which might range from mild to severe, and could include allergic reactions or other health complications. The research team will monitor you closely for any side effects and will explain these risks thoroughly before you decide to join. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (176)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama Birmingham
    Verified postcode
    Birmingham, United States
  • City of Hope
    Verified postcode
    Duarte, United States
  • Stanford University Medical Center
    Verified postcode
    Stanford, United States
  • Yale University
    Verified postcode
    New Haven, United States
  • Emory University Winship Cancer Institute
    Verified postcode
    Atlanta, United States
  • Tufts Medical Center
    Verified postcode
    Boston, United States
  • Henry Ford Hospital
    Verified postcode
    Detroit, United States
  • Henry Ford Health System
    Verified postcode
    Southfield, United States
  • Cleveland Clinic
    Verified postcode
    Cleveland, United States
  • West Penn Hospital
    Verified postcode
    Pittsburgh, United States
  • University of Pittsburgh Medical Center
    Verified postcode
    Pittsburgh, United States
  • Medical University of South Carolina
    Verified postcode
    Charleston, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the plasma cells, a type of white blood cell found in the bone marrow. These cells are part of your immune system and help fight infections. In multiple myeloma, cancerous plasma cells build up in the bone marrow and can crowd out healthy blood cells, leading to various health problems.

What does 'relapsed or refractory' mean?

'Relapsed' means your multiple myeloma has returned after initially responding to treatment. 'Refractory' means your multiple myeloma did not respond to treatment, or it progressed while you were receiving treatment.

How is the new treatment (Tec-Dara) different?

Tec-Dara combines teclistamab with daratumumab. Teclistamab is a newer type of medicine designed to help your immune system find and kill myeloma cells. Daratumumab is another targeted therapy often used for myeloma. This study is testing if combining these two medicines is more effective than current standard combinations.

Will I know which treatment I'm getting?

No, in this type of study, participants are randomly assigned to either the new treatment combination or one of the standard care combinations. This helps ensure fair comparison and accurate results, but neither you nor your doctors will choose or typically know your specific assigned treatment.

What happens after the study ends?

The care you receive after the study will depend on your health, how you responded to treatment, and what your doctors recommend for your ongoing care. The research team will explain the follow-up plans relevant to your situation.

How to find out more

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

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