Study Comparing bb2121 with Standard Treatments for Patients with Relapsed and Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is specifically for patients whose disease has returned or has not responded to previous treatments. The purpose of the study is to compare the effectiveness and safety of a new treatment called bb2121 with standard treatment options. The standard treatments being compared include medications such as Ixazomib, Elotuzumab, Pomalidomide (also known as Imnovid), Daratumumab (also known as Darzalex), Dexamethasone, Lenalidomide (also known as Revlimid), Carfilzomib (also known as Kyprolis), and Bortezomib (also known as Velcade).

The study will involve participants receiving either the new treatment, bb2121, or one of the standard treatments. The new treatment, bb2121, is a type of cell therapy that uses a patient’s own immune cells, which are modified to better fight the cancer. The study will monitor how long patients live without their disease getting worse, which is known as progression-free survival. Other aspects being observed include the overall response to treatment, the duration of response, and the safety of the treatments.

Participants will be involved in the study for a period of up to 72 weeks, during which they will receive their assigned treatment and attend regular follow-up visits. The study aims to provide valuable information on the best treatment options for patients with relapsed and refractory Multiple Myeloma, helping to improve future care and outcomes for individuals with this condition.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being tested.

2 treatment administration

The patient will receive one of the following standard regimens: DPd (daratumumab, pomalidomide, dexamethasone), DVd (daratumumab, bortezomib, dexamethasone), IRd (ixazomib, lenalidomide, dexamethasone), Kd (carfilzomib, dexamethasone), or EPd (elotuzumab, pomalidomide, dexamethasone).

Medications will be administered either orally or intravenously, depending on the specific regimen. The frequency and dosage will be determined by the healthcare provider based on the treatment plan.

3 monitoring and assessments

Regular monitoring will occur to assess the patient’s response to the treatment. This includes blood tests, imaging studies, and other necessary evaluations to track the progression of the disease and any side effects.

The primary goal is to measure progression-free survival, which is the length of time during and after treatment that the patient lives with the disease without it getting worse.

4 follow-up

After completing the treatment phase, the patient will continue to be monitored for up to 15 years. This long-term follow-up is essential to gather information on the safety and effectiveness of the treatment over time.

During this period, additional assessments may be conducted to evaluate overall survival, response rates, and quality of life.

Who Can Join the Study?

The person must be at least 18 years old when they sign the consent form.
Any side effects from previous treatments, except for hair loss and mild nerve damage, should have improved to a mild level or returned to normal.
The person must have good enough veins for a procedure called leukapheresis, which involves collecting white blood cells.
Proper birth control methods must be used as described in the study plan.
Only people who could be considered for any of the five standard treatment plans (DPd, DVd, IRd, Kd, or EPd) should join the study, as decided by the study doctor.
The person must understand and willingly sign a consent form before any study-related tests or procedures are done.
The person must be willing and able to follow the study visit schedule and other study requirements, including long-term follow-up for up to 15 years if they are in Treatment Arm A.
The person must have measurable disease, which means certain levels of proteins in the blood or urine that can be measured.
The person must have had at least 2 but no more than 4 previous treatment plans for multiple myeloma. A treatment plan can include initial treatment, with or without a stem cell transplant, and with or without ongoing maintenance therapy.
The person must have been treated before with DARA, a proteasome inhibitor, and an immunomodulatory compound for at least 2 cycles in a row.
The person must not have responded to the last treatment plan, meaning the disease got worse during or within 60 days after finishing the last treatment.
The person must have shown some improvement (minimal response or better) to at least one previous treatment plan.
The person must have a good level of daily functioning, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, with a score of 0 or 1.

Who Cannot Join the Study?

Patients who have not received at least two previous treatments for multiple myeloma, which is a type of blood cancer.
Patients who have not been treated with both an immunomodulatory compound (a drug that helps the immune system fight cancer) and a proteasome inhibitor (a drug that blocks the breakdown of proteins in cancer cells).
Patients whose disease has not shown progression (worsening) on or within 60 days after finishing their last treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Ukzvmnnvgi Hwqmakja Ctwoaxj	Cologne	Germany
Axcaxtexk Ubx	Amsterdam	The Netherlands
Ecnqsta Uoozurdtvysd Myjpxzo Czgngjt Rcnjnvbcs (oykmxid Mub	Rotterdam	The Netherlands
Ullupcmurhzjtnipkboei Wfcncaong Aqv	Wuerzburg	Germany
Aszlgrq Uycck Stzhnamnr Luctde Dq Bakfrzz	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	11.06.2019
France	Not recruiting	11.06.2019
Germany	Not recruiting	11.06.2019
Italy	Not recruiting	11.06.2019
Norway	Not recruiting	11.06.2019
Spain	Not recruiting	11.06.2019
The Netherlands	Not recruiting	11.06.2019

Trial locations

Investigated drugs:

bb2121 is a type of therapy that uses modified immune cells to target and destroy cancer cells in patients with relapsed and refractory multiple myeloma. This therapy involves taking a patient’s own immune cells, altering them in a laboratory to better recognize and attack cancer cells, and then infusing them back into the patient. The goal is to improve the patient’s progression-free survival, meaning the length of time during and after treatment that the patient lives with the disease without it getting worse.

Standard Regimens refer to the usual treatments given to patients with relapsed and refractory multiple myeloma. These can include a combination of medications that work in different ways to control the cancer. The specific drugs used in these regimens can vary, but they are typically chosen based on their effectiveness in managing multiple myeloma and may include medications that help to kill cancer cells, boost the immune system, or reduce symptoms. The study compares these standard treatments to the new therapy, bb2121, to see which is more effective in prolonging progression-free survival.

Investigated diseases:

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. Patients often experience fatigue and weakness due to anemia and may have high levels of calcium in the blood, leading to further complications. The disease typically progresses through stages, with symptoms worsening over time as more healthy bone marrow is replaced by cancerous cells.

Trial ID:

2023-509848-10-00

Protocol code:

BB2121-MM-003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing bb2121 with Standard Treatments for Patients with Relapsed and Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?