#1 Clinical Trials Search in Europe

Study of Elranatamab for Patients with Multiple Myeloma Resistant to Proteasome Inhibitors, Immunomodulatory Drugs, and Anti-CD38 Antibodies

2 1 1

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 treatment being tested in this study is a medication called Elranatamab, also known by its code name PF-06863135. This medication is given as a solution for injection under the skin, known as subcutaneous use. The purpose of the study is to determine how effective Elranatamab is in treating patients with Multiple Myeloma who have not responded to at least one type of treatment from three different categories: proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies.

Participants in the study will receive Elranatamab as a monotherapy, meaning it is the only treatment they will be given. The study is designed to observe the effects of the medication over a period of time, with a maximum treatment period of 50 weeks. During the study, participants will have regular visits to monitor their health and the effects of the treatment. The study does not involve a placebo, so all participants will receive the active medication.

The trial aims to gather information on how well Elranatamab works in treating Multiple Myeloma and to monitor any side effects that may occur. This information will help researchers understand the potential benefits and risks of using Elranatamab for this condition. The study is open-label, meaning both the researchers and participants know what treatment is being administered. The results of this study could contribute to future treatment options for patients with Multiple Myeloma.

1 initial assessment

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

Eligibility criteria include being at least 18 years old, having a prior diagnosis of multiple myeloma, and being refractory to specific treatments.

2 treatment initiation

The treatment involves the administration of elranatamab, a solution for injection.

The medication is given through subcutaneous injection, which means it is injected under the skin.

3 treatment schedule

The frequency and dosage of elranatamab are determined by the study protocol and the healthcare team overseeing the trial.

Regular monitoring is conducted to assess the response to the treatment and to manage any side effects.

4 ongoing assessments

Throughout the trial, ongoing assessments are performed to evaluate the effectiveness of the treatment.

These assessments may include blood tests, imaging studies, and other evaluations as required by the study protocol.

5 completion of treatment

The treatment phase continues until the study’s end date or until the healthcare team decides it is appropriate to stop.

The estimated end date for the trial is December 31, 2025.

6 follow-up

After completing the treatment, follow-up visits may be scheduled to monitor long-term effects and overall health.

These visits help ensure any late-onset side effects are identified and managed appropriately.

Who Can Join the Study?

  • Participants must be male or female and at least 18 years old. Female participants should not be pregnant or breastfeeding.
  • Participants should be able to perform daily activities with some limitations, as measured by the ECOG performance status of 0, 1, or 2. This is a scale that helps assess how a disease affects a patient’s daily living abilities.
  • The heart’s pumping ability, known as LVEF (Left Ventricular Ejection Fraction), should be 40% or higher, determined by specific heart tests like a MUGA scan or ECHO (echocardiogram).
  • Liver function should be adequate, with specific blood test results: Total bilirubin should be less than or equal to 2 times the upper limit of normal (ULN), or 3 times if the participant has Gilbert’s syndrome; AST and ALT should be less than or equal to 2.5 times the ULN. These are liver enzymes measured in blood tests.
  • Kidney function should be adequate, with an estimated creatinine clearance of 30 mL/min or higher. This measures how well the kidneys filter waste from the blood.
  • Bone marrow function should be adequate, with specific blood counts: ANC (Absolute Neutrophil Count) should be 1.0 x 109/L or higher; Platelets should be 25 x 109/L or higher; Hemoglobin should be 8 g/dL or higher. These are measures of blood cell levels.
  • Any side effects from previous treatments should have returned to their original state or be mild (Grade 1 or less).
  • Participants must be able to understand and sign a consent form, agreeing to follow the study’s rules and procedures.
  • Participants should be willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
  • Participants must have a prior diagnosis of Multiple Myeloma (MM) according to specific criteria set by experts.
  • The disease must be measurable based on specific criteria, such as certain levels of proteins in the blood or urine.
  • Participants must have been resistant to at least one IMiD (a type of drug used to treat MM).
  • Participants must have been resistant to at least one PI (another type of drug used to treat MM).
  • Participants must have been resistant to at least one anti-CD38 antibody (a type of treatment targeting a specific protein on MM cells).
  • Participants must have relapsed or been resistant to their last MM treatment. Refractory means the disease worsened during treatment or within 60 days after the last dose.
  • For Cohort A, participants should not have received prior BCMA-directed therapy. For Cohort B, participants should have received prior BCMA-directed ADC or BCMA-directed CAR T-cell therapy, whether approved or experimental. These are specific types of treatments targeting a protein called BCMA on MM cells.

Who Cannot Join the Study?

  • Patients with other types of cancer besides multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who have had a different cancer in the past, unless it was treated and has not come back for a long time, are excluded.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver or kidney disease are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have an active infection that requires treatment are not eligible.
  • Patients who have received another experimental treatment within a certain time frame before the study starts are excluded.
  • Patients with a history of allergic reactions to similar medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Centre Hospitalier Universitaire De Lille Lille France
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Howljvm Ssdxk Abhtosc Paris France
Avxpdcsyzi Pontczwr Hijvqygv Dc Pqvnc Paris France
Uzfymlshvv Or Aghupdn Edegem Belgium

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
07.09.2021
France France
Not recruiting
07.09.2021
Germany Germany
Not recruiting
07.09.2021
Poland Poland
Not recruiting
07.09.2021
Spain Spain
Not recruiting
07.09.2021

Trial locations

Investigated drugs:

Elranatamab is a medication being studied for its effectiveness in treating multiple myeloma, a type of blood cancer. It is used as a monotherapy, meaning it is given alone without combining it with other treatments. This trial focuses on patients whose cancer has not responded to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody. The goal is to see how well elranatamab works in these patients.

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. These cells become abnormal and multiply uncontrollably, leading to the production of abnormal proteins that can cause damage to bones and other organs. As the disease progresses, it can lead to bone pain, fractures, and anemia due to the overcrowding of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time. Symptoms can vary widely among individuals, and some may not experience noticeable symptoms in the early stages.

Trial ID:
2023-504479-25-00
Protocol code:
C1071003
NCT ID:
NCT04649359
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Norway Spain

  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway