Belantamab mafodotin Clinical Trials

What Is Belantamab mafodotin?

Belantamab mafodotin is an FDA-approved medication for Multiple Myeloma. It is a type of drug that is being studied for its effectiveness and safety in treating certain cancers. Clinical trials are investigating belantamab mafodotin both as a standalone treatment and in combination with other medications.

Researchers are exploring its use in patients whose multiple myeloma has progressed or is not responding to standard treatments. The goal of these studies is to determine if belantamab mafodotin, alone or in combination, can improve patient outcomes and be well-tolerated.

Uses and Conditions Under Study

Belantamab mafodotin is primarily being investigated for the treatment of various blood cancers, particularly those affecting plasma cells. The most prominent condition under study is Multiple Myeloma, with 44 trials focusing on this disease. This includes studies for Refractory Multiple Myeloma and Relapsed/Refractory Multiple Myeloma, which refer to cases where the cancer has returned or has not responded to previous treatments. Other related conditions being studied include Plasma Cell Myeloma, Gammopathy, Monoclonal, Paraproteinemias, Haematologic Disease, Blood Protein Disorders, and Neoplasms, each with 3 or more trials.

Beyond plasma cell disorders, belantamab mafodotin is also being evaluated for other types of lymphoma. For instance, it is being studied in participants with Plasmablastic Lymphoma and ALK+ Large B-cell Lymphoma to assess its efficacy and safety in these specific conditions.

Additionally, belantamab mafodotin is under investigation for Corneal Disease in 3 trials. The specific role of belantamab mafodotin in treating corneal disease is part of ongoing research.

Dosing

Belantamab mafodotin is administered intravenously (IV). It has been studied in various forms, including frozen and lyophilized preparations. Dosing regimens vary across clinical trials, with different strengths and frequencies being explored to determine the most effective and tolerable approach.

Some studied doses include 1.9 milligrams per kilogram (mg/kg) administered every 8 weeks for the first 24 weeks, followed by every 12 weeks. Another regimen involves 2.5 mg/kg given every 6 weeks. Other dose levels, such as 1.0 mg/kg and 1.4 mg/kg, have been investigated with varying frequencies like every 3-4 weeks (Q3/4W), every 6-8 weeks (Q6/8W), or every 9-12 weeks (Q9/12W).

Belantamab mafodotin is frequently studied in combination with other drugs for multiple myeloma, such as bortezomib, pomalidomide, lenalidomide, carfilzomib, and dexamethasone. These combination therapies explore different dosing schedules and sequences to optimize treatment outcomes. Studies also include dose optimization and escalation phases to identify appropriate dose levels for various patient populations, including those with normal or impaired hepatic and renal function.

Side Effects

In clinical studies of Belantamab mafodotin (also known as GSK2857916), participants experienced various side effects. The total number of participants in each treatment group was not consistently provided across all reported outcomes, so percentages cannot be calculated for these events. The following are counts of participants who experienced specific side effects across different studies and dose groups:

• Eye and Vision Changes: Ocular toxicities were commonly observed. In one study (NCT03525678), changes in corneal epithelium from normal to abnormal were reported in 39 to 40 participants receiving 2.5 mg/kg or 3.4 mg/kg (frozen liquid formulation), and 16 participants receiving 3.4 mg/kg (lyophilized formulation). Changes in best corrected visual acuity (BCVA) were noted in up to 45 participants across different dose groups in the same study. Increased intraocular pressure (IOP) of 22 mmHg or higher was observed in 7 to 17 participants across various dose groups. Another study (NCT03544281) reported worse grade punctate keratopathy findings in up to 10 participants and worst-case changes in BCVA scores in up to 13 participants

  Currently Recruiting Trials

  Belantamab mafodotin is currently being studied in a number of clinical trials for patients with multiple myeloma and related conditions. These studies aim to evaluate the safety and effectiveness of the drug, often in combination with other treatments, for different stages of the disease. One Phase 2 study, NCT07227311, is enrolling up to 200 participants with relapsed-refractory multiple myeloma. This trial, sponsored by GlaxoSmithKline, investigates belantamab mafodotin in combination with standard-of-care regimens such as pomalidomide and dexamethasone (BPd), bortezomib and dexamethasone (BVd), or carfilzomib and dexamethasone (BKd). The goal is to see if an extended dosing schedule of belantamab mafodotin with these combinations is effective. Another important study is the Phase 3 trial NCT06232044, targeting 88 participants. This study evaluates the safety, optimal dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone. Similarly, Massachusetts General Hospital is conducting a Phase 2 study, NCT05922501, for 50 participants with relapsed and refractory multiple myeloma, combining isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone to assess the overall response rate. Other trials explore belantamab mafodotin for specific patient populations or novel combinations. The University of Texas Southwestern Medical Center is running a Phase 1/Phase 2 study, NCT05145816, for 37 participants with relapsed or refractory AL amyloidosis, focusing on safety and dose. The Mayo Clinic is investigating alternate doses and schedules of belantamab mafodotin for 62 participants with triple-class refractory multiple myeloma in NCT05847569. Additionally, studies like NCT05573802, NCT05853965, NCT05714839, NCT05789303, NCT05091372, NCT05208307, NCT05055063, and NCT04643002 are exploring various combinations, maintenance therapies, and early-stage disease applications for belantamab mafodotin.

  Where to Participate

  Clinical trials for belantamab mafodotin are being conducted across a wide geographic area, with studies active at 55 sites in 72 cities across 29 states. This broad reach aims to make participation accessible to a diverse group of patients. Some of the top locations with multiple recruiting sites include:
  • Columbus, Ohio (6 sites)
  • Boston, Massachusetts (4 sites)
  • Nashville, Tennessee (3 sites)
  • Atlanta, Georgia (3 sites)
  • Green Bay, Wisconsin (2 sites)
  • Delaware, Ohio (2 sites)
  • Ames, Iowa (2 sites)
  • Austin, Texas (2 sites)
  • Salt Lake City, Utah (2 sites)
  • Waukesha, Wisconsin (2 sites)
  To be eligible for these studies, participants must generally be between 18 and 18 years of age. All genders are welcome to participate, but these trials are specifically for patients with the conditions being studied, meaning healthy volunteers are not being recruited, and children are not eligible.

  Development Timeline

  The journey of belantamab mafodotin began with its first clinical trial on January 21, 2015, marking the start of its development as a potential treatment. Since then, a robust research program has been established, with a total of 69 trials initiated to date, involving over 6,000 participants. The latest trial is projected to conclude on May 29, 2026, indicating ongoing long-term research efforts. GlaxoSmithKline has been a primary driver of this development, sponsoring 32 of these trials. However, a diverse group of other organizations, including academic institutions like M.D. Anderson Cancer Center and Mayo Clinic, as well as cooperative groups like the Alliance for Clinical Trials in Oncology, have also contributed significantly to the research landscape. Belantamab mafodotin's development has primarily focused on multiple myeloma, a type of blood cancer. The pipeline has expanded to investigate the drug across various stages of the disease, including relapsed/refractory multiple myeloma, newly diagnosed multiple myeloma, and even high-risk smoldering multiple myeloma. Additionally, its potential has been explored in related conditions such as AL amyloidosis. The trials have progressed through various phases, including 26 Phase 1/Phase 2 studies, 18 Phase 2 studies, 11 Phase 1 studies, and 10 Phase 3 studies, demonstrating a comprehensive approach to understanding its safety and efficacy.