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Study on the Effectiveness and Safety of Cevostamab and Tocilizumab for Patients 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 clinical trial is focused on studying a condition known as Relapsed/Refractory Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is investigating the effects of a treatment called Cevostamab, which is given as a solution through an infusion into the vein. The purpose of the study is to evaluate how effective and safe Cevostamab is for patients who have previously been treated with therapies targeting a specific protein called B Cell Maturation Antigen (BCMA) and have experienced a return or worsening of their disease.

During the study, participants will receive Cevostamab and will be monitored for their response to the treatment and any side effects they may experience. The study will also involve the use of another medication called Tocilizumab, which may be administered to manage certain side effects related to the immune system. The trial will take place over several years, with regular assessments to track the progress of the disease and the overall health of the participants.

The study aims to gather information on how well Cevostamab works in controlling the disease and improving the quality of life for patients. It will also look at how long the treatment effects last and how it impacts survival rates. By participating in this study, researchers hope to find better ways to treat Relapsed/Refractory Multiple Myeloma and improve outcomes for patients facing this challenging condition.

The research process

The trial runs in 5 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 informed about the trial's purpose, which is to evaluate the effectiveness and safety of cevostamab in patients with relapsed or refractory multiple myeloma.

    The patient will be required to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes a documented diagnosis of multiple myeloma and evidence of disease progression.

    The assessment will also consider the patient's previous treatments and overall health status.

  3. Step 3

    Treatment administration

    The patient will receive cevostamab through an intravenous (IV) infusion. The dosage and frequency will be determined by the study protocol.

    In case of certain side effects, the patient may receive tocilizumab to manage symptoms. This medication is also administered via IV infusion.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient will be regularly monitored for any changes in health status and response to the treatment.

    The study will assess the patient's response to the treatment, including any side effects experienced.

  5. Step 5

    Completion of study participation

    Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response to the study medication.

    The study is expected to continue until February 2027, with individual participation duration varying based on the treatment response and study protocol.

Who can join the trial?

8 criteria

  • Must have a documented diagnosis of multiple myeloma, which is a type of blood cancer, based on standard criteria set by experts.
  • Must show evidence of the disease getting worse, as determined by the doctor, after the last treatment.
  • Must have previously received a specific type of treatment called BCMA-targeted CAR-T or ADC therapy and have the disease return or not respond to three main types of treatments.
  • Must have previously received a treatment called BCMA-targeting T-cell-dependent bispecific antibody and have the disease return or not respond to three main types of treatments.
  • Must have an ECOG Performance Status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
  • Must have a life expectancy of at least 12 weeks.
  • Both males and females can participate.
  • Participants must be adults, typically aged 18 and older.
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Investigated drugs

Cevostamab is a medication being studied for its effectiveness and safety in patients with multiple myeloma, a type of blood cancer. This trial focuses on patients whose cancer has returned or not responded to previous treatments. Cevostamab works by targeting specific proteins on cancer cells, aiming to help the immune system recognize and destroy these cells. The study aims to determine how well cevostamab can reduce cancer symptoms and how safe it is for patients to use.

What is already known about the treatment

Cevostamab – Cevostamab is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its effectiveness and safety in treating patients with relapsed or refractory multiple myeloma, a type of blood cancer. The medication works by targeting and binding to specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Cevostamab is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with cancer cell growth and survival.

Investigated diseases

Relapsed/Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed multiple myeloma, the disease returns after a period of improvement, while refractory multiple myeloma does not respond to treatment. The disease progresses as abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and weakened immune function. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of these cancerous cells can cause significant health issues, impacting the body's ability to produce healthy blood cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505865-94-00Protocol codeCO43476Estimated enrolment92 patientsSponsorF. Hoffmann-La Roche AG

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