Active not recruitingPHASE2INTERVENTIONAL

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

This study is for people recently diagnosed with multiple myeloma who haven't had previous treatment. It aims to find the best way to use several new and existing medications, like Cilta-cel, Talquetamab, Daratumumab, Teclistamab, Bortezomib, Lenalidomide, and Dexamethasone. Researchers want to see how well these treatments work together to reduce cancer cells and keep the cancer from coming back, with the goal of achieving a long-term improvement. They'll be checking how many people show no signs of cancer cells after treatment and how long people live without their disease getting worse. The study is particularly interested if these treatments can lead to signs of a potential cure after five years.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

20 Aug 2024

Estimated completion

30 Sep 2030

Multiple Myeloma

What is this study about?

This study is for people who have recently been diagnosed with standard-risk multiple myeloma and who haven't had any treatment for it yet. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. The main goal of this study is to find out which combination of treatments works best to reduce the cancer cells and keep the cancer from getting worse. Researchers want to see if these treatments can lead to a state where there are no detectable cancer cells remaining after five years, which they call 'potential cure'.

To do this, they will be giving participants a starting treatment called induction therapy, which includes Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone. After this initial treatment, participants will receive different combinations of other medicines such as Cilta-cel, Talquetamab, and Teclistamab. The study will closely monitor how well these treatments work by looking for signs that the disease is responding and that the cancer cells are clearing up.

They will also measure 'progression-free survival,' which means how long people live without their cancer getting worse. Ultimately, the study hopes to find the most effective treatment plan to give people with newly diagnosed multiple myeloma the best chance of long-term remission, where the cancer is under control and ideally undetectable.

Key takeaways

This study is for newly diagnosed, standard-risk multiple myeloma patients.
It tests new combinations of existing and experimental drugs to improve outcomes.
The main goal is to achieve long-lasting remission, potentially like a cure.
Progression-free survival (how long the cancer is controlled) is a key measure.
Close monitoring and follow-up are part of participating in the study.

Who may be eligible?

To join this study, you must be between 18 and 70 years old and have been recently diagnosed with multiple myeloma. You shouldn't have had any treatment for multiple myeloma before. Your multiple myeloma needs to be classified as 'standard-risk' (Stages I or II), which means it's not considered high-risk at this stage.

You also need to be generally fit and able to manage daily activities, as assessed by your doctor. Your cancer needs to be measurable, meaning doctors can detect it through blood or urine tests. Finally, your general health, as assessed by a common scoring system called ECOG, should be good (a score of 0 or 1).

There are also reasons you might not be able to join. For example, if you have certain other serious health conditions, like ongoing blood disorders or another type of cancer that could come back, or if you've had a stroke or seizure recently. Also, if your multiple myeloma has spread to your brain or spinal cord, or if you have a condition called plasma cell leukemia, you wouldn't be able to take part.

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.

Are you between 18 and 70 years old?
Have you been diagnosed with multiple myeloma recently and not had treatment for it yet?
Has your doctor told you your multiple myeloma is 'standard-risk'?
Are you generally quite fit and able to do most daily activities?
Do you have measurable signs of multiple myeloma in your blood or urine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive an initial treatment, sometimes called 'induction therapy,' which involves a combination of several medications. After this, you will receive different combinations of other study medications. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how well the treatment is working and to monitor any side effects. These assessments will help doctors track your progress and see if the cancer cells are reducing.

The study will also involve follow-up appointments even after your main treatment period finishes, to continue monitoring your health and the status of your multiple myeloma for several years. The exact number of visits and the total length of your participation will depend on which treatment group you are in and how you respond to the medications. You will be given a detailed schedule if you are suitable for the study.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving state-of-the-art treatments that are not yet widely available, and having your health closely monitored by a specialist medical team. However, as with any medical treatment, there are potential risks and side effects associated with the medications used in this study. These will be fully explained to you by the study team before you decide to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

City of Hope
Verified postcode
Duarte, United States
University of California San Francisco
Verified postcode
San Francisco, United States
University of Iowa Hospital and Clinics
Verified postcode
Iowa City, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Levine Cancer Institute
Verified postcode
Charlotte, United States
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
The Alfred Hospital
Verified postcode
Melbourne, Australia
Instituto D Or de Pesquisa e Ensino
Verified postcode
Salvador, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
Verified postcode
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Verified postcode
São Paulo, Brazil
Universitaetsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
Universitaetsklinikum Tuebingen
Verified postcode
Tübingen, Germany

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells, a type of white blood cell, found in the bone marrow.

What does 'standard-risk' multiple myeloma mean?

It means your multiple myeloma is classified as less aggressive at the time of diagnosis, often corresponding to Stage I or II of the disease.

What is 'progression-free survival'?

It's the length of time during and after treatment that you live with the disease, but it doesn't get worse.

What are 'minimal residual disease (MRD)' and 'complete response (CR)'?

These terms refer to very low or undetectable levels of cancer cells after treatment, which is a good sign.

Will I receive new medications in this study?

Yes, the study involves combinations of both established and newer medications for multiple myeloma.