Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Elranatamab and Lenalidomide for Patients with Newly Diagnosed Multiple Myeloma After Stem-Cell Transplantation

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is comparing two treatments for patients who have been newly diagnosed with this condition and have undergone a procedure called autologous stem-cell transplantation, which involves using the patient's own stem cells to help restore bone marrow. The treatments being compared are Elranatamab, also known by its code name PF-06863135, and Lenalidomide, which is available in different dosages under the brand name Zelvina.

The purpose of the study is to evaluate how effective Elranatamab is compared to Lenalidomide in treating patients with Multiple Myeloma. Participants in the study will be randomly assigned to receive either Elranatamab or Lenalidomide. Elranatamab is administered as a solution for injection under the skin, while Lenalidomide is taken orally in capsule form. The study will monitor the participants over a period of time to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will have regular check-ups and tests to track their health and the progress of their Multiple Myeloma. The main goal is to determine which treatment helps patients live longer without their disease getting worse. This information will help doctors make better treatment decisions for future 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

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group receives elranatamab, and the other group receives lenalidomide.

  2. Step 2

    Elranatamab administration

    Participants in the elranatamab group receive the medication through a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

  3. Step 3

    Lenalidomide administration

    Participants in the lenalidomide group take the medication orally. The study uses Zelvina capsules, available in 15 mg, 5 mg, and 10 mg doses. The exact dosage and frequency are specified in the study protocol.

  4. Step 4

    Additional treatments

    Some participants may receive human normal immunoglobulin through an IV infusion as part of their treatment plan. This is administered as Privigen 100 mg/ml solution for infusion.

  5. Step 5

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring and assessments to evaluate their health and the effectiveness of the treatment. This includes laboratory tests and other procedures as outlined in the study protocol.

  6. Step 6

    Study duration

    The study is expected to continue until October 31, 2029. Participants remain in the study for the duration specified in the protocol, unless they choose to withdraw or are advised to stop for medical reasons.

Who can join the trial?

13 criteria

  • Participants must be at least 18 years old, or the minimum age of consent in their country if it's higher than 18.
  • Both male and female participants of childbearing potential must agree to use birth control.
  • 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 diagnosis of Multiple Myeloma with measurable disease, as defined by specific criteria involving blood and urine tests.
  • Participants should have achieved a partial response or better to previous treatment, according to specific criteria.
  • The main cancerous cell type must be identified through a specific laboratory test.
  • Participants should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The heart's ability to pump blood, measured as left ventricular ejection fraction, should be at least 40%.
  • Liver function should be adequate, with specific limits on liver enzymes and bilirubin levels.
  • Kidney function should be adequate, with a specific measure of how well the kidneys filter blood.
  • Participants must have recovered from any previous treatments, with blood cell counts and hemoglobin levels meeting specific criteria.
  • Calcium levels in the blood should be within a certain range.
  • Participants must be able to understand and sign a consent form, agreeing to follow the study's requirements and restrictions.

Who cannot join the trial?

13 criteria

  • Patients who have had another type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients who have a serious heart condition, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a condition that affects their immune system, like HIV or AIDS.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have a mental health condition that might affect their ability to participate in the study.
  • Patients who have received certain treatments for multiple myeloma in the past.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Elranatamab

    is a medication being studied for its effectiveness in treating patients with newly diagnosed multiple myeloma. It is being compared to another treatment to see how well it works in patients who have already undergone a stem-cell transplant. Elranatamab is designed to help the immune system target and destroy cancer cells.

  • Lenalidomide

    is a medication used in the treatment of multiple myeloma. It works by affecting the immune system to help slow down or stop the growth of cancer cells. In this study, lenalidomide is being used as a comparison to evaluate the effectiveness of elranatamab in patients who have had a stem-cell transplant.

What is already known about the treatment

  • Elranatamab

    Elranatamab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in patients who have undergone autologous stem-cell transplantation. The medication 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, a type of drug designed to interact with specific targets in the body.

  • Lenalidomide

    Lenalidomide is taken orally in the form of capsules. It is an established medication used in the treatment of multiple myeloma and is well-documented in medical literature. The drug functions by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent, which means it helps to regulate the immune response to fight cancer.

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. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the reduced production 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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508897-27-00Protocol codeC1071007Estimated enrolment850 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.