What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, especially those similar to Belantamab Mafodotin (an antibody-drug conjugate targeting BCMA), often have several side effects. These include grade ≥3 neutropenia, which can lead to increased risk of infections such as pneumonia. Ocular side effects like blurred vision, dry eye, and corneal ulcers are also notable, particularly with Belantamab Mafodotin. Other monoclonal antibodies targeting BCMA, such as Isatuximab, can cause upper respiratory tract infections, infusion-related reactions, and fatigue. General side effects of multiple myeloma treatments include peripheral neuropathy, gastrointestinal issues like diarrhea and constipation, and hematologic toxicities such as anemia and thrombocytopenia.

What prior FDA approvals exist?

Belantamab Mafodotin, an antibody-drug conjugate targeting BCMA, was approved for the treatment of relapsed/refractory multiple myeloma. Other similar treatments include Teclistamab, a bispecific monoclonal antibody targeting BCMA and CD3, which recruits T cells to kill BCMA-expressing myeloma cells. Additionally, Isatuximab, a monoclonal antibody, has been used in combination therapies for relapsed/refractory multiple myeloma. These treatments represent a class of therapies focusing on targeting specific antigens on myeloma cells to enhance immune-mediated destruction.

What other types of research exist?

Promising novel alternatives to Belantamab Mafodotin for Multiple Myeloma patients include: 1) CAR T-cell therapies targeting BCMA, such as idecabtagene vicleucel and ciltacabtagene autoleucel, which have shown high response rates in clinical trials. 2) Bispecific T-cell engagers (BiTEs) like teclistamab, which also target BCMA and have demonstrated encouraging efficacy. 3) Other antibody-drug conjugates (ADCs) targeting different antigens, such as those directed at GPRC5D or FcRH5, which are in various stages of clinical development.

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Belantamab Mafodotin for Multiple Myeloma

Phase 1

Recruiting

Led By Neeraj Saini

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if belantamab mafodotin can help prevent multiple myeloma from returning after a stem cell transplant. It focuses on patients who have had this transplant and are at risk of relapse. The drug works by targeting and killing cancer cells.

Who is the study for?

This trial is for adults aged 18-75 with relapsed/refractory multiple myeloma after at least two prior treatments, including specific standard agents. Participants must have a partial response or better to previous therapies, adequate blood counts and organ function, and no history of certain other diseases or recent monoclonal antibody treatment.

What is being tested?

The study tests if Belantamab Mafadotin (Blenrep) can prevent the return of multiple myeloma after an autologous stem cell transplant. It also examines the drug's safety post-transplant in patients who've had this type of therapy before or are undergoing it for the first time.

What are the potential side effects?

Potential side effects include vision issues like blurry eyesight due to corneal problems, low blood cell counts which could increase infection risk or cause fatigue, liver enzyme changes suggesting liver damage, and infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 1 & 2 trial • 153 Patients • NCT03544281

75%

Keratopathy

42%

Visual acuity reduced

42%

Diarrhoea

42%

Insomnia

33%

Dizziness

33%

Urinary tract infection

33%

Neutrophil count decreased

25%

COVID-19

25%

Platelet count decreased

25%

Cough

17%

Upper respiratory tract infection

17%

Pneumonia

17%

Atrial fibrillation

17%

Anaemia

17%

Vertigo

17%

Cataract nuclear

17%

Foreign body sensation in eyes

17%

Abdominal pain

17%

Constipation

17%

Nausea

17%

Oedema peripheral

17%

Infusion related reaction

17%

Gamma-glutamyltransferase increased

17%

Headache

17%

Back pain

17%

Muscle spasms

17%

Muscular weakness

17%

Pain in extremity

17%

Anxiety

17%

Rash

Inguinal hernia

Hypertension

Cellulitis

Pseudomonas infection

Septic shock

Acute myocardial infarction

Cardiac failure congestive

Colitis

Pyrexia

Tricuspid valve incompetence

Lymphopenia

Thrombocytopenia

Cardiac failure

Mitral valve incompetence

Asthenopia

Blepharitis

Blepharospasm

Cataract

Cataract cortical

Dry eye

Eye irritation

Eye pain

Squamous cell carcinoma of skin

Meibomian gland dysfunction

Gastrooesophageal reflux disease

Haemorrhoids

Balance disorder

Paraesthesia oral

Asthenia

Feeling abnormal

Oedema

Hypertransaminasaemia

Gastroenteritis

Nail infection

Nasopharyngitis

Oral candidiasis

Respiratory tract infection

Viral infection

Chemical burns of eye

Contusion

Blood alkaline phosphatase increased

Weight decreased

Hyperglycaemia

Hypertriglyceridaemia

Hypocalcaemia

Hypokalaemia

Hypomagnesaemia

Hypophosphataemia

Bone pain

Bursitis

Myalgia

Lethargy

Paraesthesia

Peripheral sensory neuropathy

Restless legs syndrome

Tremor

Delirium

Acute kidney injury

Urinary incontinence

Vulvovaginal pruritus

Dyspnoea

Dyspnoea exertional

Epistaxis

Haemoptysis

Oropharyngeal discomfort

Blister

Cold urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex

Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex

Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex

Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex

Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Belantamab mafodotinExperimental Treatment1 Intervention

belantamab mafodotin by vein over 30 minutes every 8 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belantamab mafodotin

2022

Completed Phase 2

~240

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments often target specific mechanisms to combat the disease. Antibody-drug conjugates (ADCs) like Belantamab Mafodotin target B cell maturation antigen (BCMA) on myeloma cells, delivering cytotoxic agents directly to the cancer cells, which helps to minimize damage to healthy cells. Proteasome inhibitors, such as bortezomib, disrupt protein degradation in myeloma cells, leading to cell death. Immunomodulatory drugs like lenalidomide enhance the immune system's ability to fight cancer. Monoclonal antibodies, such as daratumumab, target specific proteins on myeloma cells to mark them for immune destruction. These targeted therapies are crucial as they offer more effective and personalized treatment options, potentially improving outcomes and reducing side effects for Multiple Myeloma patients.

Belantamab Mafodotin for the Treatment of Multiple Myeloma: An Overview of the Clinical Efficacy and Safety.Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.Sorafenib for the treatment of multiple myeloma.