#1 Clinical Trials Search in Europe

Study of belantamab mafodotin with bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma patients eligible for transplant

2 1 1 1

What is this study about?

This study focuses on patients with Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The research examines a combination treatment using several medications: belantamab mafodotin (given through intravenous injection), lenalidomide (taken as oral capsules), bortezomib (given as an injection under the skin), and dexamethasone (taken as oral tablets). This treatment combination is being tested in patients who have been newly diagnosed with multiple myeloma and are eligible for stem cell transplantation.

The main purpose of this research is to evaluate whether the combination of these medications is safe and well-tolerated by patients during their initial treatment. The study will monitor how patients respond to the treatment and track any side effects that may occur. The treatment period consists of six cycles of therapy, during which patients will receive different combinations of the study medications.

Throughout the study, patients will undergo regular medical examinations and tests to monitor their health status. These include blood tests to check blood cell counts, tests to evaluate liver and kidney function, and eye examinations. The researchers will also track how well the cancer responds to the treatment and how long these responses last. Patients will be monitored for potential side effects for several months after completing the treatment.

1 Initial treatment phase

You will receive treatment in 6 cycles combining several medications:

– Belantamab mafodotin through intravenous infusion

– Lenalidomide capsules taken by mouth

– Bortezomib given as injection under the skin

– Dexamethasone tablets taken by mouth

Regular blood tests will monitor your health during treatment

2 Eye examinations

Regular eye examinations will be performed to check for any changes in your vision

Your eye health will be monitored throughout the treatment period

3 Disease monitoring

Your response to treatment will be regularly assessed through blood and urine tests

Tests will check for signs of multiple myeloma (bone marrow cancer) activity

4 Safety monitoring

Regular checks of your:

– Blood cell counts

– Liver function

– Kidney function

– General health status

5 Long-term follow-up

Your health status will be monitored after completing the initial treatment

Follow-up will continue until May 2025

Who Can Join the Study?

  • Must be newly diagnosed with multiple myeloma with symptoms according to current medical criteria
  • Must have measurable disease levels shown by either:
    – Blood protein level ≥0.5 g/dl, or
    – Urine protein level ≥200 mg in 24 hours
  • Must be eligible for stem cell transplant (a procedure where damaged bone marrow is replaced with healthy cells)
  • Must have good enough physical function to perform daily activities (ECOG score of 2 or less)
  • Must be at least 18 years old
  • Must have adequate organ function, including:
    – Sufficient blood cell counts
    – Normal liver function
    – Kidney function of at least 30 mL/min
    – Normal calcium levels
  • For women who can become pregnant:
    – Must not be pregnant or breastfeeding
    – Must use effective birth control during treatment and for 4 months after
    – Must have negative pregnancy tests before starting treatment
  • For men:
    – Must use contraception during treatment and for 6 months after
    – Must agree not to donate sperm during this period
  • Must have any side effects from previous treatments resolved to mild level or less
  • Must be able to understand and agree to study procedures by providing written consent

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous treatment for multiple myeloma
  • Known hypersensitivity (severe allergic reaction) to study medications
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Significant heart conditions, including heart failure or recent heart attack (within 6 months)
  • Severe kidney dysfunction
  • Severe liver problems
  • Active other cancer within the last 3 years
  • Pregnancy or breastfeeding
  • Unable to follow study procedures
  • History of severe eye problems or current eye conditions
  • Uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study
  • Mental conditions that could interfere with study participation
  • Current participation in other clinical trials

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Universitario Infanta Leonor Madrid Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital Clinic De Barcelona Barcelona Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Son Llatzer Palma Spain
Hospital Universitario De Canarias La Laguna Spain
Hqxkrzwr Ujcmcoxdbfxdt Mplwxhj Da Veveszmevq Santander Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
26.04.2021

Trial locations

Investigated drugs:

Belantamab mafodotin is a medication used to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on cancer cells to help destroy them while limiting damage to healthy cells.

VRd is a combination therapy that consists of three medications:
– Velcade (bortezomib): A medication that blocks certain proteins to slow or stop cancer cell growth
– Revlimid (lenalidomide): A medication that helps strengthen the immune system’s ability to fight cancer cells
– dexamethasone: A steroid medication that reduces inflammation and suppresses the immune system to help fight cancer

These medications are being studied together as a treatment for people who have been newly diagnosed with multiple myeloma and are eligible for transplant.

Investigated diseases:

Multiple myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow, pushing out healthy blood cells and creating abnormal proteins. The disease usually develops gradually and affects multiple bones in the body. As it progresses, it can cause bone pain, weakness, frequent infections, and changes in kidney function. Multiple myeloma typically affects several different parts of the body, particularly where there is active bone marrow.

Trial ID:
2024-516130-35-00
Protocol code:
GEM-BELA-VRd‬
NCT ID:
NCT04802356
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Norway Spain

  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway