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Study on the Safety and Effects of Forimtamig, Tocilizumab, and Daratumumab in 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 called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is testing a treatment called Forimtamig, which is being evaluated for its safety and how well it works when used alone or in combination with other treatments. The other treatments being studied in combination with Forimtamig include Actemra (tocilizumab), Darzalex (daratumumab), Kyprolis (carfilzomib), Diphenhydramine, and Dexamethasone. These medications are used in different forms such as tablets, solutions for infusion, and injections.

The purpose of this study is to understand how safe and tolerable Forimtamig is for patients, as well as to observe its preliminary effects on the cancer. Participants in the study will receive Forimtamig either by itself or alongside the other mentioned treatments. The study will monitor the participants over a period of time to see how their bodies respond to the treatment combinations. This includes looking at any side effects and how the cancer responds to the treatment.

The study is designed to gather information on the effectiveness of Forimtamig in treating relapsed or refractory Multiple Myeloma, which means the cancer has returned or is not responding to previous treatments. The trial will help determine the best way to use Forimtamig in combination with other drugs to improve outcomes for patients with this type of cancer. The study is expected to continue until 2027, providing valuable insights into the treatment of Multiple Myeloma.

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, a documented diagnosis of multiple myeloma is required. Agreement to provide specific bone marrow samples is necessary.

    An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 is required, indicating full activity or some symptoms but nearly fully ambulatory.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility, including a review of previous treatments and current health status.

    Life expectancy must be at least 12 weeks, and evidence of progressive disease is required.

  3. Step 3

    Treatment phase

    The treatment involves the administration of forimtamig alone or in combination with other medications.

    Medications include diphenhydramine (oral), tocilizumab (infusion), forimtamig (injection), dexamethasone (oral), daratumumab (injection), and carfilzomib (infusion).

    The specific dosage, frequency, and duration of each medication will be determined by the study protocol and the healthcare team.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring will occur to assess the safety and tolerability of the treatment. This includes tracking any adverse events and the body's response to the medications.

    The study aims to evaluate the preliminary anti-tumor activity of forimtamig based on objective response rate and other response criteria.

  5. Step 5

    Follow-up

    Follow-up assessments will be conducted to evaluate progression-free survival, duration of response, and overall survival.

    The presence of anti-drug antibodies and serum concentrations of forimtamig will be assessed during the study.

Who can join the trial?

7 criteria

  • Agreement to provide specific samples from the bone marrow, which is a soft tissue inside bones.
  • Have an ECOG Performance Status of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
  • Have a life expectancy of at least 12 weeks.
  • Have a confirmed diagnosis of multiple myeloma (MM) according to specific medical guidelines.
  • Show signs of the disease getting worse based on a doctor's assessment after the last treatment.
  • Have received previous treatment for relapsed/refractory multiple myeloma (r/r MM), including specific types of drugs known as immunomodulatory drugs (IMiDs) and proteasome inhibitors (PI). Participants who have or have not been treated with anti-CD38 drugs are allowed.
  • Both male and female participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer within the last 5 years, except for certain skin cancers or in situ cancers, which are very early-stage cancers.
  • Patients who have had a recent heart attack or have severe heart problems.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have received certain treatments for multiple myeloma within a specific time frame before the study.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.
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Investigated drugs

Forimtamig is a medication being studied for its safety and effectiveness in treating patients with multiple myeloma, a type of blood cancer. The trial is exploring how well this medication works when used alone or in combination with other treatments. The goal is to see if it can help reduce the cancer or improve the patient's condition.

What is already known about the treatment

Forimtamig – Forimtamig is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory multiple myeloma, a type of blood cancer. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. It is classified as an immunotherapy agent, which is a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a kind 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 and other organs. As the disease progresses, it can result in bone pain, fractures, and anemia due to the crowding out of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses in a series of relapses and remissions, with symptoms worsening over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503689-21-00Protocol codeBP43437Estimated enrolment135 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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