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Study on Elranatamab and Daratumumab for Patients with Relapsed or Refractory Multiple Myeloma After Prior Treatment

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 different treatments to see how effective and safe they are for people whose disease has returned or has not responded to previous treatments. The treatments being tested include a new medication called Elranatamab (also known by its code name PF-06863135), which is given as an injection. The study will also look at the combination of Elranatamab with another medication called Daratumumab, and compare it to a combination of Daratumumab with two other drugs, Pomalidomide and Dexamethasone.

The purpose of the study is to find out which treatment works best for patients with relapsed or refractory Multiple Myeloma. Participants in the study will be randomly assigned to one of three groups. One group will receive Elranatamab alone, another group will receive Elranatamab combined with Daratumumab, and the third group will receive Daratumumab combined with Pomalidomide and Dexamethasone. The study will monitor the participants over a period of time to see how their disease responds to the treatment and to check for any side effects.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the progress of their treatment. The study aims to provide valuable information that could help improve treatment options for people with Multiple Myeloma in the future. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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, eligibility is confirmed based on specific criteria, including age, prior diagnosis of multiple myeloma, and previous treatments.

    Participants must have measurable disease and meet health requirements such as adequate heart, liver, and kidney function.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of three treatment groups: elranatamab alone, elranatamab with daratumumab, or daratumumab with pomalidomide and dexamethasone.

  3. Step 3

    Treatment administration

    For those receiving elranatamab, it is administered as a subcutaneous injection.

    Participants in the daratumumab group receive it as a subcutaneous injection.

    Those in the pomalidomide and dexamethasone group take these medications orally, with pomalidomide available in 1 mg, 2 mg, 3 mg, and 4 mg capsules, and dexamethasone as 40 mg tablets.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the safety and effectiveness of the treatment.

    This includes checking for any side effects and measuring the response to treatment using specific criteria.

  5. Step 5

    End of treatment

    The study continues until the estimated end date in September 2026, or until the treatment is no longer beneficial.

    Participants may continue to be monitored for long-term effects and overall health outcomes.

Who can join the trial?

10 criteria

  • Participants must be **18 years or older**.
  • Must have a **prior diagnosis of multiple myeloma**, a type of blood cancer.
  • Must have a **measurable disease** based on specific criteria, such as certain levels of proteins in the blood or urine.
  • Must have had **previous treatments for multiple myeloma**:
    • For Part 1: At least 3 previous treatments, including specific drugs like lenalidomide and a proteasome inhibitor (PI).
    • For Part 2: Between 1 and 3 previous treatments, including lenalidomide and a PI, with a positive response to any of these treatments.
    • Must have an **ECOG performance status** of less than 2, which means they should be able to carry out daily activities with some limitations.
    • Must have a **left ventricular ejection fraction (LVEF)** of 40% or higher, which is a measure of heart function.
    • Must have **adequate liver, kidney, and bone marrow function**.
    • Must have **normal levels of calcium** in the blood.
    • Any **side effects from previous treatments** must have returned to normal or be mild.

Who cannot join the trial?

13 criteria

  • Patients with 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 cervical cancer.
  • Patients who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
  • Patients who have received certain treatments for multiple myeloma within a specific time frame before the study.
  • Patients with known allergies to the study drugs or similar drugs.
  • Patients who have participated in another clinical trial within a certain period before this study.
  • Patients with certain heart conditions or who have had a heart attack within the last 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with certain lung conditions that could affect breathing.
  • Patients with liver or kidney problems that are not well controlled.
  • Patients with a history of drug or alcohol abuse within the last 2 years.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

  • Elranatamab (PF-06863135)

    is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. In this trial, it is being tested both on its own and in combination with another medication to see how well it works and how safe it is for patients who have already tried other treatments.

  • Daratumumab

    is a medication used to treat multiple myeloma. It works by helping the immune system to find and destroy cancer cells. In this study, it is being used in combination with other medications to see if it can improve treatment outcomes for patients.

  • Pomalidomide

    is a medication that helps the immune system fight cancer and is used to treat multiple myeloma. In this trial, it is combined with other drugs to evaluate its effectiveness in patients who have not responded well to previous treatments.

  • Dexamethasone

    is a type of steroid that reduces inflammation and is used in combination with other medications to treat multiple myeloma. In this study, it is part of a treatment regimen to assess its role in improving patient outcomes.

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, a type of blood cancer. It is being evaluated both as a standalone treatment and in combination with other drugs. Elranatamab works by targeting specific proteins on 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.

  • Daratumumab

    This medication is given as an injection and is already approved for use in treating multiple myeloma. It is being studied further in combination with other drugs to enhance its effectiveness. Daratumumab works by binding to a specific protein on the surface of cancer cells, marking them for destruction by the immune system. It belongs to the class of monoclonal antibodies, which are designed to target and eliminate cancer cells.

  • Pomalidomide

    This medication is taken orally and is used in the treatment of multiple myeloma, particularly in patients who have not responded to other treatments. It is being studied in combination with other drugs to improve outcomes. Pomalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory agent, which helps to enhance the body's natural defense against cancer.

  • Dexamethasone

    This medication is administered orally or by injection and is commonly used in combination with other drugs to treat multiple myeloma. It is being studied further to optimize its use in combination therapies. Dexamethasone works by reducing inflammation and suppressing the immune response, which can help control cancer growth. It is classified as a corticosteroid, which is often used to manage symptoms and enhance the effectiveness of cancer treatments.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly and produce abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also interfere with the production of normal blood cells, leading to further complications. Over time, the disease can cause significant damage to various organs and systems in the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509208-14-00Protocol codeC1071005Estimated enrolment856 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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