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Study on the Safety and Effects of Forimtamig, Tocilizumab, and Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Odense University Hospital Odense Denmark
Amppga Uqvvcsgyty Havtrpgr Aarhus Denmark
Azhrgnd Ostmphzuhpi Ugfogdjuhiagc Ccapyaaikdtu Dutzu Sletgl E Dvghg Svtldjl Dj Tmmcoy Turin Italy
Apturbe Ujxps Slskxmggb Lrvnmt Dk Bbdwcap Bologna Italy
Hfkoyrcu Upuugmdrrcvlc Msbnkzh Dg Vqzkbayvyj Santander Spain
Ulmqfmdpugwjmeniqaebt Aafwgwwi Augsburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
25.08.2023
France France
Not recruiting
25.08.2023
Germany Germany
Not recruiting
25.08.2023
Italy Italy
Not recruiting
25.08.2023
Spain Spain
Not recruiting
25.08.2023

Trial locations

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.

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 ID:
2023-503689-21-00
Protocol code:
BP43437
Trial Phase:
Human Pharmacology (Phase I) – Other

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