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Study Comparing Belantamab Mafodotin with Pomalidomide and Dexamethasone to Bortezomib with Pomalidomide and Dexamethasone for Patients with Relapsed/Refractory 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 condition called Relapsed/Refractory Multiple Myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study is comparing two different treatment combinations to see which is more effective. One combination includes Belantamab Mafodotin, Pomalidomide, and Dexamethasone, while the other includes Bortezomib, Pomalidomide, and Dexamethasone. The purpose of the study is to evaluate the effectiveness and safety of these treatments in patients with this type of multiple myeloma.

Participants in the study will receive one of the two treatment combinations. The study will monitor how the disease responds to the treatments and how long the response lasts. It will also look at the overall survival of participants, which means the length of time participants live after starting the treatment. The study will also assess any side effects that may occur and how the treatments affect the quality of life of the participants.

The study will take place over a period of time, with regular check-ups and assessments to track the progress of the disease and the effects of the treatment. Participants will be randomly assigned to one of the treatment groups, and some may receive a placebo as part of the study. The goal is to gather information that could help improve treatment options for people with relapsed or refractory multiple myeloma in the future.

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

    Joining the study

    Upon joining the study, participants are randomly assigned to one of two treatment groups. The study aims to compare the effectiveness of two different treatment combinations for relapsed or refractory multiple myeloma.

  2. Step 2

    Treatment group assignment

    Participants are assigned to either the B-Pd group or the PVd group. The B-Pd group receives a combination of belantamab mafodotin, pomalidomide, and dexamethasone. The PVd group receives bortezomib, pomalidomide, and dexamethasone.

  3. Step 3

    Medication administration

    In the B-Pd group, belantamab mafodotin is administered intravenously. Pomalidomide is taken orally in capsule form, and dexamethasone is taken orally in tablet form.

    In the PVd group, bortezomib is administered subcutaneously. Pomalidomide is taken orally in capsule form, and dexamethasone is taken orally in tablet form.

  4. Step 4

    Treatment schedule

    The treatment is administered in cycles. Each cycle lasts 28 days. The specific dosage and frequency of each medication are determined by the study protocol and may vary based on individual response and tolerance.

  5. Step 5

    Monitoring and assessments

    Participants undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging studies, and other necessary evaluations.

  6. Step 6

    Study duration

    The study is expected to continue until February 2025. Participants will remain in the study until disease progression, unacceptable side effects, or withdrawal of consent.

Who can join the trial?

12 criteria

  • Must be able to give signed informed consent, which means you understand the study and agree to participate.
  • Both men and women must agree to follow the study's rules about birth control.
  • Must be 18 years old or older.
  • Must have a confirmed diagnosis of multiple myeloma, a type of blood cancer, according to specific medical guidelines.
  • Must have an ECOG performance status of 0 to 2, which is a scale that measures how well you can perform daily activities. A score of 0 means fully active, while 2 means you are up and about more than half the day.
  • Must have been treated with at least one previous therapy for multiple myeloma, including a treatment with a drug called lenalidomide, and the disease must have gotten worse during or after the last treatment. You are eligible if you took lenalidomide at a dose of 10 mg or more daily for at least two cycles in a row.
  • Must have at least one measurable sign of the disease, such as:
    • Urine M-protein excretion of 200 mg or more in 24 hours, or
    • Serum M-protein concentration of 0.5 grams per deciliter or more, or
    • Serum free light chain (FLC) level of 10 mg/dL or more, with an abnormal FLC ratio, if there is no measurable urine or serum M spike.
    • Must have had an autologous stem cell transplant (ASCT) or be considered not eligible for a transplant. If you had ASCT, it must have been more than 100 days before starting the study medication, and you must not have any active infections.
    • Any side effects from previous treatments must be mild (Grade 1 or less) at the time of joining the study, except for hair loss.
    • Must have adequate organ function as specified in the study protocol.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than Relapsed/Refractory Multiple Myeloma cannot participate. This means the study is only for those with a specific type of blood cancer that has returned or is not responding to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have certain medical conditions that might interfere with the study or make it unsafe for them cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who are currently participating in another clinical trial cannot participate, as this could affect the results of the study.
  • Patients who have had a recent major surgery or are recovering from a major surgery cannot participate, as this could affect their health during the study.
  • Patients who have a history of certain heart problems or other serious health issues cannot participate, as these conditions could make the study unsafe for them.
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Investigated drugs

  • Belantamab Mafodotin

    is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It works by targeting and killing cancer cells, helping to control the disease.

  • Pomalidomide

    is a medication that helps the immune system fight cancer. It is used in combination with other drugs to treat multiple myeloma, especially when the disease has returned or is not responding to other treatments.

  • Dexamethasone

    is a steroid that reduces inflammation and helps control symptoms of multiple myeloma. It is often used in combination with other cancer treatments to enhance their effectiveness.

  • Bortezomib

    is a medication that interferes with the growth of cancer cells and slows their spread in the body. It is used to treat multiple myeloma and is often combined with other drugs to improve treatment outcomes.

What is already known about the treatment

  • Belantamab Mafodotin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma. It is an antibody-drug conjugate that targets a specific protein on the surface of cancer cells, delivering a toxic agent directly to the cells to inhibit their growth. Belantamab Mafodotin is classified as an anti-cancer agent and is being evaluated for its potential to improve outcomes in patients with this type of cancer.

  • Pomalidomide

    This medication is taken orally and is used in the treatment of relapsed or refractory multiple myeloma. It works by modulating the immune system and inhibiting the growth of cancer cells. Pomalidomide is classified as an immunomodulatory agent and is well-established in medical literature as a treatment option for multiple myeloma.

  • Dexamethasone

    This medication is administered orally or intravenously and is used in combination with other drugs to treat relapsed or refractory multiple myeloma. It is a corticosteroid that reduces inflammation and suppresses the immune response, helping to manage symptoms and enhance the effectiveness of other cancer treatments. Dexamethasone is widely used in various medical conditions and is well-documented in medical literature.

  • Bortezomib

    This medication is administered intravenously or subcutaneously and is used in the treatment of relapsed or refractory multiple myeloma. It works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. Bortezomib is classified as a proteasome inhibitor and is a well-established treatment in the management of multiple myeloma.

Investigated diseases

Relapsed/Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer has returned after treatment (relapsed) or does not respond to treatment (refractory). It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to complications like anemia and high calcium levels in the blood. As it progresses, it becomes more challenging to manage and may require different therapeutic approaches.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506877-37-00Protocol code207499Estimated enrolment295 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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