What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving monoclonal antibodies like Belantamab Mafodotin, often result in side effects such as neutropenia, infections (including upper respiratory tract infections and pneumonia), and infusion-related reactions. For instance, Isatuximab, another BCMA-targeting antibody, is associated with high rates of neutropenia and respiratory infections. Other treatments like Carfilzomib and Bortezomib, often used in combination with dexamethasone, can cause fatigue, hypertension, gastrointestinal issues, and peripheral neuropathy. These treatments may also lead to more severe complications such as cardiac events and renal failure.

What prior FDA approvals exist?

Belantamab Mafodotin, an antibody-drug conjugate targeting B cell maturation antigen (BCMA), was approved for the treatment of relapsed/refractory multiple myeloma but has been withdrawn from the U.S. market. Other similar treatments include Isatuximab, a monoclonal antibody targeting CD38, which has shown efficacy in combination with other drugs like pomalidomide and dexamethasone. Teclistamab, another bispecific monoclonal antibody targeting BCMA and CD3, has also been authorized for relapsed/refractory multiple myeloma. These treatments represent a class of therapies that leverage the immune system to target and kill myeloma cells.

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 (Abecma) and Ciltacabtagene Autoleucel (Carvykti), which have shown significant efficacy in clinical trials. 2) Bispecific antibodies targeting BCMA and CD3, such as Teclistamab, which have demonstrated promising results in early-phase studies. 3) Other antibody-drug conjugates like MEDI2228, which targets BCMA and is currently under investigation. These therapies offer new mechanisms of action and have shown potential in improving outcomes for multiple myeloma patients.

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Monoclonal Antibodies

Belantamab Mafodotin for Multiple Myeloma (DREAMM-3 Trial)

Q: What is the mechanism of action of this treatment?

Multiple Myeloma treatments often target specific proteins on myeloma cells to inhibit their growth and survival. Belantamab Mafodotin, an ADC, targets BCMA on myeloma cells, delivering cytotoxic agents directly to the cancer cells, thereby minimizing damage to healthy cells. Other common treatments include proteasome inhibitors (e.g., bortezomib and carfilzomib), which block the proteasome's function, leading to the accumulation of toxic proteins within the cancer cells and inducing cell death. Immunomodulatory drugs (e.g., lenalidomide and pomalidomide) enhance the immune system's ability to attack myeloma cells and inhibit their growth. Monoclonal antibodies (e.g., daratumumab and isatuximab) target specific antigens on myeloma cells, marking them for destruction by the immune system. These targeted therapies are crucial for MM patients as they offer more effective and less toxic treatment options compared to traditional chemotherapy, improving survival rates and quality of life.

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

All prior treatment-related toxicities must be <=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy

Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent

Must not have

History of (non-infectious) pneumonitis that required steroids, or current pneumonitis

Evidence of active mucosal or internal bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug called belantamab mafodotin in patients with multiple myeloma that has returned or not responded to treatment. Belantamab mafodotin targets cancer cells directly, while pomalidomide boosts the immune system, and dexamethasone controls inflammation.

Who is the study for?

Adults with relapsed/refractory multiple myeloma who've had at least two prior treatments, including lenalidomide and a proteasome inhibitor, can join. They must have measurable disease levels, adequate organ function, and no major surgery or active infections recently. Pregnant women, those with certain medical conditions or previous BCMA-targeted therapy are excluded.

What is being tested?

The trial compares belantamab mafodotin (administered every three weeks) against pomalidomide plus low-dose dexamethasone (pomalidomide daily for 21 days of a 28-day cycle; dexamethasone weekly). Participants will be randomly assigned to one of these treatments until their disease progresses or they experience unacceptable side effects.

What are the potential side effects?

Belantamab mafodotin may cause vision issues like blurry eyesight and corneal problems. Pom/dex can lead to weakened immune system responses, increased risk of infections, blood clots, fatigue, bone thinning and mood swings due to steroid use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My side effects from previous treatments are mild, except for hair loss and some nerve pain.

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I am at least 18 years old, or over 19 if I am from the Republic of Korea.

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I've had at least 2 treatments for myeloma, including lenalidomide and a proteasome inhibitor, but my disease still progressed.

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I can take care of myself and am up and about more than half of my waking hours.

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I have multiple myeloma and have had or can't have a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or have it now.

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I am currently experiencing bleeding from an internal site.

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I have symptoms of amyloidosis, POEMS syndrome, or plasma cell leukemia currently.

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I cannot tolerate blood clot prevention treatments.

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I haven't taken any myeloma treatment or experimental drugs recently.

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My liver condition is stable.

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I have had a stem cell transplant from a donor.

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I have a mild eye surface condition, not severe.

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I am currently being treated for an infection.

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I have an active kidney condition.

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I have not undergone plasmapheresis within the last week.

Select...

I have previously received BCMA-targeted therapy or pomalidomide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG)

Secondary study objectives

Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)

Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein (Grams Per Liter)

Change From Baseline in Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Magnesium, Blood Urea Nitrogen (BUN), and Phosphorous (Millimoles Per Liter)

+31 more

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Participants receiving Belantamab mafodotinExperimental Treatment1 Intervention

Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W

Group II: Participants receiving pom/dexActive Control1 Intervention

Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belantamab mafodotin

2022

Completed Phase 2

~240

0 / 17Eligibility criteria met

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 proteins on myeloma cells to inhibit their growth and survival. Belantamab Mafodotin, an ADC, targets BCMA on myeloma cells, delivering cytotoxic agents directly to the cancer cells, thereby minimizing damage to healthy cells. Other common treatments include proteasome inhibitors (e.g., bortezomib and carfilzomib), which block the proteasome's function, leading to the accumulation of toxic proteins within the cancer cells and inducing cell death. Immunomodulatory drugs (e.g., lenalidomide and pomalidomide) enhance the immune system's ability to attack myeloma cells and inhibit their growth. Monoclonal antibodies (e.g., daratumumab and isatuximab) target specific antigens on myeloma cells, marking them for destruction by the immune system. These targeted therapies are crucial for MM patients as they offer more effective and less toxic treatment options compared to traditional chemotherapy, improving survival rates and quality of life.

An update on B-cell maturation antigen-targeted therapies in Multiple Myeloma.Sorafenib for the treatment of multiple myeloma.Advances in multiple myeloma therapy during two past decades.