Study on the Effectiveness of Talquetamab and Teclistamab in First-Line Treatment for Transplant-Eligible Multiple Myeloma Patients

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What is this study about?

This clinical trial is focused on studying the treatment of Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will use a combination of medications, including teclistamab (also known by the code name JNJ-64007957), talquetamab (code name JNJ-64407564), lenalidomide, dexamethasone, bortezomib, and darzalex (which contains the active substance daratumumab). These medications are designed to help the immune system target and destroy cancer cells.

The purpose of the study is to determine if adding T-cell redirectors, which are a type of treatment that helps the immune system recognize and attack cancer cells, to the first line of treatment will improve the depth of response in patients. This means the study aims to see if this approach can increase the number of patients who achieve a state where no cancer cells can be detected, known as minimal residual disease (MRD) negativity, and a complete response, where all signs of cancer are gone.

Participants in the study will receive these treatments over a period of time, with the goal of improving their response to the therapy. The study will involve several cycles of treatment with the medications mentioned, and the progress will be monitored to see how well the cancer responds. The study will also include a comparison with a placebo to evaluate the effectiveness of the treatment. The overall aim is to find a more effective treatment strategy for patients with Multiple Myeloma.

1 initial treatment phase

The initial treatment phase involves the administration of several medications to manage multiple myeloma. This phase includes the use of daratumumab, bortezomib, lenalidomide, and dexamethasone. These medications are administered through subcutaneous injections and oral routes.

The goal of this phase is to reduce the disease burden and prepare for the next stages of treatment.

2 consolidation therapy with talquetamab

Following the initial treatment, consolidation therapy with talquetamab is administered. This involves subcutaneous injections over a period of 6 cycles.

The purpose of this therapy is to further decrease the presence of cancer cells and achieve a deeper response.

3 consolidation therapy with teclistamab

After completing talquetamab therapy, consolidation therapy with teclistamab is initiated. This also involves subcutaneous injections over 6 cycles.

This step aims to enhance the treatment response and increase the likelihood of achieving minimal residual disease (MRD) negativity.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes measuring MRD using advanced techniques and evaluating overall health.

Follow-up assessments are scheduled to track the long-term effects of the treatment and ensure the maintenance of the achieved response.

Who Can Join the Study?

Participants must be between 18 and 70 years old.
Total bilirubin levels must be less than 1.5 times the upper limit of normal. If you have Gilbert’s syndrome, a condition that affects bilirubin levels, you may still qualify if your direct bilirubin is less than 1.5 times the upper limit.
HIV-positive participants can join if they have no detectable viral load, a CD4+ count greater than 300 cells/mm³, no serious infections related to AIDS in the past 6 months, and are on stable HIV treatment. Changes in treatment due to resistance should be made at least 3 months before joining, and changes due to side effects are allowed up to 4 weeks before joining.
Women who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study and for 100 days after the last treatment.
Women must either not be able to have children or agree to use effective birth control methods, such as abstinence, a partner with a vasectomy, or two effective contraception methods, with at least one being highly effective.
Women must agree not to donate eggs or freeze them for future use during the study and for 6 months after the last treatment.
Men must use condoms during any activity that could result in pregnancy during the study and for at least 100 days after the last treatment. If their partner can have children, she must also use a highly effective birth control method.
Men must agree not to donate sperm during the study and for at least 100 days after the last treatment.
Participants must sign a consent form indicating they understand the study’s purpose and procedures and are willing to participate.
Participants must be willing and able to follow the lifestyle restrictions specified in the study protocol.
Participants must have documented multiple myeloma, a type of blood cancer, meeting specific criteria.
Participants must be newly diagnosed and eligible for high-dose therapy and a procedure called autologous stem cell transplant (ASCT).
Participants must have an ECOG performance status score of 2 or less, which measures their ability to perform daily activities.
Hemoglobin levels must be at least 8 g/dL, and red blood cell transfusions are allowed.
Platelet levels must be at least 75 x 10⁹/L if less than 50% of bone marrow cells are plasma cells, or at least 50 x 10⁹/L if 50% or more are plasma cells, without recent transfusion support.
Absolute neutrophil count (ANC) must be at least 1.0 x 10⁹/L, with prior growth factor support allowed but not within 7 days for certain growth factors.
AST and ALT liver enzyme levels must be less than 2.5 times the upper limit of normal.
Estimated creatinine clearance rate (eCFR) must be at least 30 mL/min, which measures kidney function.

Who Cannot Join the Study?

Patients who have a different condition than Multiple Myeloma cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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

Other Sites

Site Name	City	Country
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Rigshospitalet	Copenhagen	Denmark
North Estonia Medical Centre Foundation	Tallin	Estonia

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	08.04.2024
Estonia	Not recruiting	08.04.2024
Norway	Not recruiting	08.04.2024

Trial locations

Investigated drugs:

Talquetamab is a medication used in this clinical trial as part of the first line treatment for multiple myeloma. It is a bispecific T-cell redirector, which means it helps the immune system target and destroy cancer cells more effectively. The goal is to improve the depth of response in patients, aiming for a higher rate of minimal residual disease negativity and complete response.

Teclistamab is another bispecific T-cell redirector used in the trial alongside Talquetamab. Like Talquetamab, it works by directing the body’s immune cells to attack multiple myeloma cells. The combination of these two medications is being studied to see if it can enhance the treatment outcomes for patients by increasing the likelihood of achieving minimal residual disease negativity and complete response.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. These proteins can cause damage to bones and organs, particularly the kidneys. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also interfere with the production of normal blood cells, leading to various complications. Over time, the disease can cause significant health issues, impacting the quality of life.

Trial ID:

2023-508212-38-00

Protocol code:

TALTEC JNJ-54767414

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Talquetamab and Teclistamab in First-Line Treatment for Transplant-Eligible Multiple Myeloma Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?