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A Study of Linvoseltamab Alone and Linvoseltamab with Carfilzomib Compared to Standard Treatment in Adults with Relapsed or 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 study is looking at relapsed refractory multiple myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow and has come back or has not responded to previous treatments. The study will test two different treatment approaches using linvoseltamab, which is a medicine designed to help the immune system fight cancer cells. One treatment approach will use linvoseltamab on its own, while the other will combine linvoseltamab with another cancer medicine called carfilzomib. These two approaches will be compared to standard treatment combinations that may include medicines such as pomalidomide, daratumumab, bortezomib, and dexamethasone. Some patients may also receive supportive medicines like aciclovir, paracetamol, co-trimoxazole, and diphenhydramine hydrochloride to help manage side effects or prevent infections.

The purpose of this study is to find out if treatment with linvoseltamab alone or linvoseltamab combined with carfilzomib works better than standard treatments for multiple myeloma that has returned or stopped responding to previous therapy. The study will measure how many patients have no signs of cancer cells remaining in their body after twelve months of treatment and how long patients live without their cancer getting worse. The study will also look at how safe these treatments are and what side effects patients may experience.

The study has two parts. In the first part, a small number of patients will receive linvoseltamab or linvoseltamab with carfilzomib to check that the dosing schedule is safe. In the second part, a larger group of patients will be randomly assigned to receive either linvoseltamab alone, linvoseltamab with carfilzomib, or standard treatment combinations. Patients will receive their assigned treatment in cycles lasting twenty-eight days. During the study, patients will have regular check-ups, blood tests, and other examinations to see how well the treatment is working and to monitor for any side effects. The study will also ask patients questions about their quality of life and how they are feeling.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be assigned to one of three treatment groups. The assignment will be done randomly, similar to flipping a coin.

    The three possible treatment groups are: Arm A (receiving linvoseltamab alone), Arm B (receiving linvoseltamab combined with carfilzomib), or Arm C (receiving standard therapy combinations).

  2. Step 2

    Preventive medications

    Before starting the main treatment, you will receive medications to prevent potential side effects.

    These include paracetamol (pain reliever and fever reducer) taken by mouth or given through a vein, diphenhydramine hydrochloride (antihistamine to prevent allergic reactions) taken by mouth or given as injection, and dexamethasone (anti-inflammatory medication) given through a vein or taken by mouth.

    You may also receive aciclovir tablets (200 mg) by mouth to prevent viral infections, and co-trimoxazole tablets (80/400 mg) by mouth to prevent certain bacterial infections.

  3. Step 3

    Initial treatment phase - Arm A

    If you are assigned to Arm A, you will receive linvoseltamab through a vein as an infusion.

    The treatment will begin with a step-up dosing schedule, where the dose is gradually increased. Initial doses include 5 mg and 200 mg formulations given as concentrate for infusion.

    The exact frequency and duration of infusions will be determined based on your response to treatment and tolerability.

  4. Step 4

    Initial treatment phase - Arm B

    If you are assigned to Arm B, you will receive a combination of linvoseltamab and carfilzomib.

    Linvoseltamab will be given through a vein as an infusion, starting with a step-up dosing schedule using 5 mg and 200 mg formulations.

    Carfilzomib will be given through a vein as an infusion, available in doses of 10 mg, 30 mg, or 60 mg as powder for solution.

    Both medications will be administered according to a schedule determined by the study protocol.

  5. Step 5

    Initial treatment phase - Arm C

    If you are assigned to Arm C, you will receive standard therapy, which may include one of several combination regimens.

    One possible combination includes daratumumab (1800 mg) given under the skin as injection, pomalidomide capsules (1 mg, 2 mg, 3 mg, or 4 mg) taken by mouth, and dexamethasone given through a vein or taken by mouth.

    Another possible combination includes carfilzomib (10 mg, 30 mg, or 60 mg) given through a vein, dexamethasone given as infusion (4 mg/ml or 8 mg/2 ml formulations) or taken by mouth.

    A third possible combination includes bortezomib (3.5 mg) given through a vein as injection, pomalidomide capsules taken by mouth, and dexamethasone.

    The specific regimen and dosing schedule will be determined according to standard treatment protocols.

  6. Step 6

    Ongoing treatment cycles

    Treatment will continue in cycles. The length of each cycle and the number of cycles will depend on which treatment group you are assigned to and how your disease responds.

    Throughout treatment, you will continue to receive preventive medications as needed to manage potential side effects.

    Treatment will continue as long as your disease does not progress and you do not experience unacceptable side effects.

  7. Step 7

    Regular monitoring visits

    During the study, you will have regular visits for monitoring and assessments.

    Blood samples will be collected to measure drug levels in your bloodstream and to check for minimal residual disease (very small amounts of cancer cells that may remain after treatment).

    Your overall health status, physical functioning, and any side effects will be assessed regularly.

    You will be asked to complete questionnaires about your quality of life, symptoms, and how treatment affects your daily activities.

  8. Step 8

    Response assessment

    At specific time points, particularly at 12 months, your response to treatment will be evaluated.

    This includes checking whether you have achieved complete response (no detectable cancer), very good partial response, or partial response (cancer has decreased significantly).

    Testing will also determine if you have achieved MRD-negative complete response, meaning no cancer can be detected even with very sensitive tests.

  9. Step 9

    Long-term follow-up

    After completing the main treatment phase, you will continue to be followed for an extended period.

    This follow-up will track your overall survival, time until disease progression, and time until you need to start a new treatment.

    The study is expected to continue until 2034, though your individual participation duration may vary based on your treatment response and disease status.

Who can join the trial?

8 criteria

  • You must have relapsed refractory multiple myeloma, which means your cancer has come back or did not respond to previous treatment
  • You must have received at least 1 but no more than 3 previous treatment plans for your cancer
  • Your previous treatments must have included a medicine called lenalidomide and either a protease inhibitor (a type of drug that blocks certain proteins in cancer cells) or an anti-CD38 monoclonal antibody (a type of drug that targets specific proteins on cancer cells)
  • Your ECOG performance status score must be 2 or lower, which is a measure of how well you can perform daily activities, where 0 means fully active and higher numbers indicate more limitations
  • Your disease must have gotten worse during or after your most recent treatment, confirmed by specific medical criteria
  • You must be an adult
  • Both men and women can participate in this study
  • Other requirements may apply as defined by the study protocol

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed information about who cannot join this clinical trial, it is not possible to list the specific medical conditions, treatments, or situations that would prevent participation
  • Generally, clinical trials may exclude patients based on factors such as other serious illnesses, recent treatments, laboratory test results that fall outside acceptable ranges, or allergies (negative reactions to medications), but these specific details are not available in the provided information
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Investigated drugs

  • Linvoseltamab

    is a medicine being tested to treat multiple myeloma, which is a type of blood cancer. This medication works by helping the body's immune system recognize and attack cancer cells. In this study, it is being used alone or in combination with another medication.

  • Carfilzomib

    is a cancer medicine that is used to treat multiple myeloma. It works by blocking certain proteins in cancer cells, which helps to stop the cancer from growing. In this study, it is being tested in combination with linvoseltamab.

What is already known about the treatment

  • Linvoseltamab

    Linvoseltamab is an experimental cancer medication currently being studied in clinical trials for the treatment of multiple myeloma that has come back or stopped responding to previous treatments. It is given as an injection into a vein and works by helping the body's immune system recognize and attack cancer cells through a special protein structure that connects immune cells to myeloma cells. This medication belongs to a class of drugs called bispecific antibodies, which are designed to bind to two different targets at once: one on the cancer cell and one on the immune cell. In this clinical trial, it is being tested alone and in combination with another cancer drug called carfilzomib to see if it can help patients achieve better disease control compared to standard treatment options.

  • Carfilzomib

    Carfilzomib is an approved cancer medication used to treat multiple myeloma, a type of blood cancer affecting plasma cells in the bone marrow. It is administered through an intravenous infusion, typically given in cycles over several weeks, and works by blocking a cellular structure called the proteasome, which normally breaks down old or damaged proteins inside cancer cells. By preventing the proteasome from functioning properly, carfilzomib causes harmful proteins to build up inside myeloma cells, leading to their death. This medication belongs to a class of drugs known as proteasome inhibitors and is often used in combination with other cancer treatments to improve effectiveness in patients whose disease has returned or is no longer responding to initial therapy.

Investigated diseases

Relapsed Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are white blood cells that produce antibodies in the bone marrow. In this condition, the cancer has either returned after a period of improvement (relapsed) or has not responded to previous treatments (refractory). The abnormal plasma cells multiply uncontrollably and accumulate in the bone marrow, crowding out healthy blood cells. As the disease progresses, it can cause weakening of bones, reduced production of normal blood cells, and buildup of abnormal proteins in the blood. The condition continues to advance despite previous therapies, making it more challenging to manage. Patients with this form of the disease have already undergone multiple lines of treatment without achieving lasting control of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519504-27-00Protocol codeR5458-ONC-2246Estimated enrolment866 patientsSponsorRegeneron Pharmaceuticals Inc.

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