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Monoclonal Antibodies

Belantamab Mafodotin for Multiple Myeloma

Phase 1
Recruiting
Led By Hans Lee
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
Patients must be diagnosed with high-risk smoldering multiple myeloma (SMM) as confirmed by bone marrow plasmacytosis with ≥ 10% plasma cells, immunoparesis, and ≥ 95% aberrant plasma cells by flow cytometry
Creatinine clearance (CrCl) ≥ 30 ml/min
Must not have
Plasma cell leukemia
Active hepatitis B or C infection, known HIV infection, or known hypersensitivity reaction to drugs chemically related to belantamab mafodotin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial is designed to find the best dose of Belantamab Mafodotin for safety and efficacy in patients with high-risk smoldering multiple myeloma, with a maximum of 30 patients.

Who is the study for?
This trial is for adults with high-risk smoldering multiple myeloma who haven't had prior treatments. Participants need to have good kidney and liver function, be able to perform daily activities (ECOG 0-2), and agree to contraception. It's not for pregnant women, those with active hepatitis B/C or HIV, recent major surgery patients, or people with heart disease.Check my eligibility
What is being tested?
The study tests Belantamab Mafodotin's safety and optimal dose in two parts: finding the best dose among 18 patients then confirming it in another 12. The main goal is to see how well the drug works against this type of cancer by measuring response rates.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions related to immune system activation, infusion-related symptoms, organ inflammation due to antibody-drug conjugates like Belantamab Mafodotin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high-risk smoldering multiple myeloma with specific blood and bone marrow conditions.
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My kidneys are working well enough (CrCl ≥ 30 ml/min).
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I agree to use contraception and not donate sperm.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I have smoldering myeloma and haven't been treated for it yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with plasma cell leukemia.
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I do not have active hepatitis B or C, HIV, or allergies to drugs similar to belantamab mafodotin.
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My tests show signs of myeloma.
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I have used steroids, radiation, or chemotherapy for smoldering multiple myeloma.
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I have not had major surgery in the last month.
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I do not have cirrhosis or current unstable liver or biliary disease.
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I don't have active kidney issues, internal bleeding, or recent monoclonal antibody treatment.
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I have an eye condition like severe dry eye or use contact lenses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the recommended Phase 2 dose (RP2D) or maximum tolerated dose of single agent belantamab mafodotin in high risk SMM.

Side effects data

From 2024 Phase 1 & 2 trial • 153 Patients • NCT03544281
92%
Keratopathy
54%
Vision blurred
46%
Diarrhoea
38%
Platelet count decreased
31%
Nausea
31%
Neutrophil count decreased
31%
Fatigue
31%
Anaemia
31%
Visual acuity reduced
23%
Constipation
23%
Arthralgia
23%
Back pain
23%
Neutropenia
15%
Infusion related reaction
15%
Visual acuity tests abnormal
15%
Muscle spasms
15%
Influenza like illness
15%
Rhinovirus infection
15%
Foreign body sensation in eyes
15%
Thrombocytopenia
15%
Agitation
15%
Atrial fibrillation
15%
COVID-19
15%
Hyperglycaemia
15%
Osteonecrosis of jaw
15%
Skin laceration
15%
Pain in extremity
15%
Upper respiratory tract infection
8%
Asthenia
8%
Campylobacter gastroenteritis
8%
Incarcerated inguinal hernia
8%
Anal haemorrhage
8%
Peripheral sensory neuropathy
8%
Erectile dysfunction
8%
Sinus bradycardia
8%
Pneumothorax
8%
Lymphopenia
8%
Dry mouth
8%
Device related infection
8%
Ejection fraction decreased
8%
Weight decreased
8%
Cough
8%
Weight increased
8%
Tinnitus
8%
Campylobacter infection
8%
Respiratory tract infection
8%
Contusion
8%
Blood creatinine increased
8%
Arthritis
8%
Migraine
8%
Sensory loss
8%
Diplopia
8%
Abdominal distension
8%
Dyspepsia
8%
Gastrooesophageal reflux disease
8%
Irritable bowel syndrome
8%
Urinary tract pain
8%
Conjunctival haemorrhage
8%
Gingivitis
8%
Pneumocystis jirovecii pneumonia
8%
Haemorrhoids
8%
Musculoskeletal chest pain
8%
Cataract
8%
Hypokalaemia
8%
Insomnia
8%
Lethargy
8%
Memory impairment
8%
Photophobia
8%
Rectal haemorrhage
8%
Eye pain
8%
Aspartate aminotransferase increased
8%
Rash
8%
Epistaxis
8%
Actinic keratosis
8%
Neuroendocrine tumour
8%
Skin cancer
8%
Limb injury
8%
Decreased appetite
8%
Abdominal discomfort
8%
Flatulence
8%
Hyperuricaemia
8%
Oropharyngeal pain
8%
Anxiety
8%
Atrial flutter
8%
Palpitations
8%
Abdominal pain upper
8%
Gingival pain
8%
Abdominal pain
8%
Liver function test abnormal
8%
Oedema peripheral
8%
Lumbar spinal stenosis
8%
Electrocardiogram QT prolonged
8%
Myalgia
8%
Neck pain
8%
Hiccups
8%
Rhinorrhoea
8%
Periodontitis
8%
Purpura
8%
Hypotension
8%
Cerebrovascular accident
8%
Anal incontinence
8%
Urticaria
8%
Skin abrasion
8%
Petechiae
8%
Vomiting
8%
Eye infection
8%
Pneumonia
8%
Bronchitis
8%
Bone pain
8%
Chronic kidney disease
8%
Proteinuria
8%
Hypertension
8%
Skin ulcer
8%
Inguinal hernia
8%
Gastroenteritis
8%
Blood creatine phosphokinase increased
8%
Nasopharyngitis
8%
Skin lesion
8%
Gastroenteritis norovirus
8%
Troponin T increased
8%
Alanine aminotransferase increased
8%
Dyspnoea
8%
Pyrexia
8%
Erythema
8%
COVID-19 pneumonia
8%
Lower respiratory tract infection
8%
Staphylococcus test positive
8%
Hypercalcaemia
8%
Paraesthesia
8%
Confusional state
8%
Pruritus
8%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 3.4 mg/kg SINGLE + 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 1.9 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belantamab mafodotinExperimental Treatment1 Intervention
belantamab mafodotin by vein over 30-60 minutes on Day 1 of each 56-day cycle for the first 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,249 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,782 Patients Enrolled for Multiple Myeloma
Hans LeePrincipal InvestigatorM.D. Anderson Cancer Center
Elisabet ManasanchPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
32 Total Patients Enrolled
~16 spots leftby Feb 2027
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