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Study Comparing Elranatamab, Daratumumab, and Lenalidomide with Daratumumab, Lenalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

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 disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing different combinations of treatments to see which works best for people who cannot have a transplant. The treatments being studied include Elranatamab (also known by its code name PF-06863135), Daratumumab, Lenalidomide, and Dexamethasone. These medications are used to help control the disease and improve the quality of life for patients.

The purpose of the study is to compare the effectiveness and safety of two different treatment combinations. One group will receive Elranatamab, Daratumumab, and Lenalidomide, while the other group will receive Daratumumab, Lenalidomide, and Dexamethasone. The study will follow participants over a period of time to see how well the treatments work and to monitor any side effects. Participants will receive their treatments either as tablets, capsules, or injections, depending on the medication.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their treatment. The study aims to find out which combination of treatments is more effective in managing Multiple Myeloma for those who are not eligible for a transplant. This research is important for improving treatment options and outcomes for patients with this condition.

The research process

The trial runs in 4 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 such as age, health status, and diagnosis of multiple myeloma.

    Participants are divided into two groups for the study: one group receives a combination of elranatamab, daratumumab, and lenalidomide, while the other group receives daratumumab, lenalidomide, and dexamethasone.

  2. Step 2

    Treatment phase

    Participants in the first group receive elranatamab as a solution for injection, daratumumab as a subcutaneous injection, and lenalidomide in capsule form for oral use.

    Participants in the second group receive daratumumab as a subcutaneous injection, lenalidomide in capsule form for oral use, and dexamethasone in tablet form for oral use.

    The treatment is administered over a specified period, with regular monitoring to assess the body's response and any side effects.

  3. Step 3

    Monitoring and assessment

    Throughout the study, regular assessments are conducted to monitor the effectiveness of the treatment and any adverse effects.

    These assessments include blood tests, imaging studies, and other evaluations to measure disease progression and response to treatment.

  4. Step 4

    Completion of the study

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

    Participants may be offered follow-up care or additional treatment options based on the results of the study.

Who can join the trial?

9 criteria

  • Participants must be at least 18 years old, or the minimum age of consent in their country if it's higher than 18.
  • For Part 2 only: Participants should have newly diagnosed multiple myeloma (NDMM) and be unable to have a transplant. This could be due to being 65 years or older, or being younger than 65 with other health issues that make a transplant not possible.
  • Participants should have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that measures how well a person can perform daily activities.
  • Participants need to have proper liver, kidney, and bone marrow function. This includes having enough white blood cells, platelets, and hemoglobin, which is a protein in red blood cells.
  • Participants should have normal levels of calcium in their blood.
  • Any side effects from previous treatments should have returned to normal or be mild.
  • Participants must have a diagnosis of multiple myeloma, which is a type of blood cancer, according to specific criteria.
  • Participants should have measurable disease, meaning the cancer can be measured in some way, according to specific criteria.
  • For Part 1 only: Participants can have newly diagnosed multiple myeloma (NDMM) or relapsed/refractory multiple myeloma (RRMM). NDMM participants must be unable to have a transplant due to age or other health issues. RRMM participants should have had 1-2 previous treatments, including at least one type of drug that affects the immune system and one that targets proteins in cells.

Who cannot join the trial?

10 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.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of allergic reactions to similar medications used in the study.
  • Patients with uncontrolled high blood pressure or heart problems.
  • Patients with liver or kidney problems that are not stable.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • Elranatamab (PF-06863135)

    is an investigational medication being studied for its potential to treat multiple myeloma. It is being tested in combination with other medications to see if it can help improve outcomes for patients who are not eligible for a transplant.

  • Daratumumab

    is a medication used to treat multiple myeloma. It works by targeting a specific protein on the surface of myeloma cells, helping the immune system to destroy them. In this trial, it is used in combination with other medications to evaluate its effectiveness in newly diagnosed patients.

  • Lenalidomide

    is a medication that helps the immune system fight cancer cells and is commonly used in the treatment of multiple myeloma. It is being used in this study to see how well it works with other medications in treating patients who cannot undergo a transplant.

  • Dexamethasone

    is a type of steroid that helps reduce inflammation and is often used in combination with other cancer treatments. In this trial, it is part of a treatment regimen to assess its role in improving patient outcomes when used with other medications for multiple myeloma.

What is already known about the treatment

  • Elranatamab

    Elranatamab 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 not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for Elranatamab is multiple myeloma, particularly in patients who are not eligible for transplant. At the molecular level, 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 cancer therapy.

  • Daratumumab

    Daratumumab is administered via intravenous infusion and is an established medication used in the treatment of multiple myeloma. It is well-documented in medical literature and is approved for use in various treatment regimens for this condition. The main therapeutic indication for Daratumumab is multiple myeloma, where it helps to slow the progression of the disease. It works by binding to a specific protein on the surface of myeloma cells, leading to their destruction by the immune system. Daratumumab is classified as a monoclonal antibody.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form and is widely used in the treatment of multiple myeloma. It is a well-established medication with extensive documentation in medical literature. The primary therapeutic indication for Lenalidomide is multiple myeloma, where it helps to inhibit the growth of cancer cells and enhance the immune response against them. It works by modulating the immune system and inhibiting the formation of new blood vessels that tumors need to grow. Lenalidomide is classified as an immunomodulatory agent.

  • Dexamethasone

    Dexamethasone is administered orally or intravenously and is a commonly used medication in the treatment of multiple myeloma. It is well-documented in medical literature and is often used in combination with other drugs to enhance their effectiveness. The main therapeutic indication for Dexamethasone is multiple myeloma, where it helps to reduce inflammation and suppress the immune response. It works by mimicking the effects of hormones produced by the adrenal glands, which can help to reduce the activity of the immune system. Dexamethasone is classified as a corticosteroid.

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 cells become abnormal and multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of abnormal plasma cells can lead to anemia and other blood-related issues. The disease often progresses slowly, but it can become more aggressive in some cases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514139-50-00Protocol codeC1071006Estimated enrolment1 060 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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