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

Verified siteInvestigationalNo 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 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.

The research process

The trial runs in 6 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 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

16 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

Elranatamab – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in patients who have not responded to other treatments. It is in the investigational stage and is not yet widely available in medical practice. Elranatamab works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with cancer cell growth.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504479-25-00Protocol codeC1071003Estimated enrolment72 patientsSponsorPfizer Inc.

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