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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

bb2121 – This medication is administered through an intravenous infusion, specifically designed for patients with relapsed and refractory multiple myeloma who have undergone at least two prior therapies. Currently, bb2121 is being evaluated in clinical trials to assess its effectiveness compared to standard treatments. It is primarily indicated for multiple myeloma, particularly in cases where the disease has progressed despite previous treatments. At the molecular level, bb2121 works by targeting and modifying T-cells to recognize and attack cancer cells, utilizing a mechanism known as CAR-T cell therapy. It falls under the pharmacological classification of immunotherapy, specifically as a chimeric antigen receptor T-cell therapy.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509848-10-00Protocol codeBB2121-MM-003Estimated enrolment386 patientsSponsorCelgene Corp.

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