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Study of Elranatamab for Treating Relapsed or Refractory Multiple Myeloma in Patients Previously Treated with Three Drug Classes

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What is this study about?

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is testing a treatment called Elranatamab, which is given as a solution for injection under the skin. The purpose of the study is to evaluate how effective Elranatamab is in treating patients whose multiple myeloma has returned or has not responded to previous treatments.

Participants in the study will receive Elranatamab as a single treatment. The study will observe patients over a period of time to see how their disease responds to the treatment. The researchers will look at how many patients have no detectable signs of the disease at 6 and 12 months. This will help determine the effectiveness of Elranatamab in managing multiple myeloma.

The study is open-label, meaning both the researchers and participants know what treatment is being given. It is conducted at multiple centers, allowing for a broader range of participants. The study will continue until the disease progresses, the participant decides to withdraw, or the study reaches its end date. This trial aims to provide valuable information on the potential benefits of Elranatamab for patients with relapsed or refractory multiple myeloma.

1 joining the study

Upon joining the study, the patient will undergo a screening phase to ensure eligibility. This includes meeting specific health criteria and providing informed consent.

2 treatment initiation

The patient will begin treatment with elranatamab, a solution for injection administered subcutaneously. The dosage and frequency will be determined by the study protocol and the patient’s condition.

3 treatment phase

During the treatment phase, the patient will receive regular doses of elranatamab. The patient’s response to the treatment will be monitored closely by the study team.

4 monitoring and evaluation

The patient’s health and response to the treatment will be evaluated at regular intervals. This includes assessing the rate of undetectable measurable residual disease at 6 and 12 months.

5 completion of study

The study is considered complete for the patient if they are followed until disease progression, withdrawal of consent, loss to follow-up, death, or the end of the study.

Who Can Join the Study?

  • Patients must have relapsed multiple myeloma, meaning the disease has returned after treatment, and have received 1 or 2 previous treatments.
  • Patients must have been treated with at least one proteasome inhibitor (such as bortezomib, carfilzomib, or ixazomib), one immunomodulatory drug (lenalidomide is required, and they may have also used pomalidomide), and at least one anti-CD38 monoclonal antibody (such as daratumumab or isatuximab).
  • Patients must have certain blood test results before starting the study, including specific levels of hemoglobin, neutrophils, platelets, liver enzymes (AST and ALT), bilirubin, kidney function (creatinine clearance), and calcium.
  • Women who can have children must use a highly effective method of birth control and have a negative pregnancy test before starting treatment.
  • Men participating in the study must agree to use contraception or remain abstinent from heterosexual intercourse during the study and for at least 100 days after.
  • Patients must show evidence of progressive disease, meaning the disease is getting worse, or have not responded to their last treatment.
  • Patients must have a measurable secretory disease, which means certain proteins in the blood or urine are at specific levels.
  • Participants must be 18 years or older.
  • Patients must be able to follow the study’s requirements, according to the investigator’s opinion.
  • Patients must have a prior diagnosis of multiple myeloma according to specific criteria.
  • Patients must provide written informed consent to participate in the study, understanding they can withdraw at any time.
  • Patients must have an ECOG performance status of 0 or 1, which indicates they are fully active or have some symptoms but do not require bed rest.
  • Patients must have a left-ventricular ejection fraction (LVEF) of 40% or higher, which is a measure of heart function.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Multiple Myeloma cannot participate.
  • Patients who have not experienced a return or worsening of Multiple Myeloma after treatment are excluded.
  • Patients who are under the age of 18 or over the age of 65 are not eligible.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not allowed to join 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
Hospital Universitario De Salamanca Salamanca Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario De Leon Leon Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Son Llatzer Palma Spain
Hospital Universitario Lucus Augusti Lugo Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hojnrxam Uaunyktfltqkt Dg Cninusuk Gijon Spain
Hegwyltz Upnznyotaupna Mfvjhwa Do Vzhiolseko Santander Spain
Injfiwxt Cavdjc Dyagpbprpdaovjhun L'hospitalet De Llobregat Spain
Hffxncdn Uwcutipevbidj Hystlpxt Tmdcy y Pkebfa Iqwoqpqh Cgzays dojcluonzxwshtfpk (mwsc Badalona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
08.07.2023

Trial locations

Investigated drugs:

Elranatamab is being studied as a treatment for patients with multiple myeloma, a type of blood cancer, who have not responded to previous treatments. This medication is being tested to see how effective it is when used alone in patients who have already tried other types of cancer drugs. The goal is to determine if it can help reduce or eliminate the cancer cells in these patients.

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, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells. Over time, the disease can cause significant complications, affecting various organs and systems in the body.

Trial ID:
2023-504273-21-00
Trial Phase:
Therapeutic exploratory (Phase II)

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