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Study on the Safety and Efficacy of Cevostamab with Lenalidomide or Iberdomide for Patients with High-Risk or Relapsed 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 treatments for Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study involves several medications, including Iberdomide, Cevostamab, Lenalidomide (also known as Revlimid), and Tocilizumab (also known as RoActemra). Iberdomide is taken as a capsule, while Cevostamab and Tocilizumab are given as solutions for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients with Multiple Myeloma. The study is divided into different parts, each focusing on specific combinations of medications. For example, one part of the study looks at the combination of Cevostamab and Lenalidomide in patients who have high-risk features and are receiving maintenance treatment after their first response to therapy. Another part examines the combination of Cevostamab and Iberdomide in patients whose disease has returned or is not responding to previous treatments.

Participants in the study will receive the study medications and be monitored for their response to the treatment and any side effects. The study aims to gather information on how well the treatments work and how safe they are for patients with Multiple Myeloma. This information will help in understanding the potential benefits and risks of these treatments for patients with this 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include a diagnosis of multiple myeloma and a performance status that allows participation in the study.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves evaluating the safety of the study medications. This includes monitoring for any side effects and determining the most suitable dosage.

    Medications used in this phase include iberdomide and cevostamab, administered either orally or through intravenous infusion.

  3. Step 3

    Treatment phase 2

    In the second phase, the focus shifts to evaluating the effectiveness of the treatment. This involves measuring the response to the medication and monitoring disease progression.

    The goal is to achieve a complete or partial response, with regular assessments to track progress.

  4. Step 4

    Maintenance treatment

    For patients who respond well to initial treatments, a maintenance phase may be introduced. This involves continued administration of lenalidomide and cevostamab to sustain the response.

    The maintenance phase aims to prolong the period without disease progression.

  5. Step 5

    Follow-up and monitoring

    Throughout the study, regular follow-up visits are scheduled to monitor health status and any potential side effects.

    These visits help ensure the safety and effectiveness of the treatment over time.

Who can join the trial?

7 criteria

  • The patient must have been diagnosed with multiple myeloma (MM), which is a type of blood cancer, according to specific medical guidelines.
  • The patient should have an Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • For Substudy 1, the patient must have a current or past diagnosis of MM, whether it's the first time or a later occurrence, including during maintenance therapy, which is ongoing treatment to help keep cancer from coming back.
  • For Substudy 2, the patient should have completed their initial treatment plan and achieved at least a partial response (PR), meaning the cancer has shrunk but is still present.
  • For Substudy 4, the patient must have previously been treated with at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody for relapsed or refractory MM, which means the cancer has returned or is not responding to treatment, and there are no suitable standard treatment options available.
  • Both male and female patients are eligible to participate.
  • The study does not include vulnerable populations, which means groups that might need special protection or care.

Who cannot join the trial?

8 criteria

  • Patients who have not been diagnosed with Multiple Myeloma (MM) cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible to join this study.
  • Patients who have allergies or reactions to the study medications or similar drugs cannot participate.
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Investigated drugs

  • Cevostamab

    is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It is being tested in combination with other treatments to see if it can help improve outcomes for patients who have already undergone a stem cell transplant or have relapsed or refractory multiple myeloma.

  • Lenalidomide

    is a medication used in the treatment of multiple myeloma. In this study, it is combined with cevostamab to evaluate its effectiveness as a maintenance treatment for patients who have received a stem cell transplant and are at high risk of their disease returning.

  • Iberdomide

    is another medication being tested in combination with cevostamab. This study aims to understand how well this combination works for patients whose multiple myeloma has returned or has not responded to previous treatments. The study also looks at how the body processes these medications and their overall safety.

What is already known about the treatment

  • Cevostamab

    Cevostamab is administered intravenously and is currently being studied in clinical trials for its potential use in treating multiple myeloma, particularly in patients with high-risk features or those who have relapsed. It works by targeting 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, a type of medication designed to bind to specific targets in the body.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form and is an established medication used in the treatment of multiple myeloma. It is known for its ability to modulate the immune system and inhibit the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent, which helps enhance the body's immune response against cancer.

  • Iberdomide

    Iberdomide is administered orally and is currently under investigation in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma. It functions by modulating the immune system and promoting the destruction of cancer cells. Iberdomide is part of the class of drugs known as immunomodulatory agents, which are designed to boost the immune system's ability to fight cancer.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to issues like anemia, bone damage, and kidney problems. As the disease progresses, it can cause bone pain, frequent infections, and fatigue due to the overproduction of abnormal proteins. These proteins can also lead to kidney damage and other complications. The disease often progresses in stages, starting with a smoldering or asymptomatic phase, and can eventually lead to more severe symptoms and complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504484-16-00Protocol codeCO43923Estimated enrolment170 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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