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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study 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.

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
100%
Keratopathy
58%
Platelet count decreased
50%
Diarrhoea
42%
Nausea
42%
Aspartate aminotransferase increased
42%
Vision blurred
42%
Constipation
42%
Lymphocyte count decreased
33%
Visual acuity reduced
33%
Oedema peripheral
33%
Fatigue
33%
COVID-19
25%
Abdominal pain
25%
Insomnia
25%
Back pain
25%
Thrombocytopenia
17%
Neuropathy peripheral
17%
Hyperglycaemia
17%
Hypokalaemia
17%
Vomiting
17%
Contusion
17%
Rash
17%
Hypertension
17%
Anaemia
17%
Blood creatine phosphokinase increased
17%
Neutrophil count decreased
17%
Pyrexia
17%
Alanine aminotransferase increased
17%
Bone pain
17%
Myalgia
8%
Kidney infection
8%
Pneumonia
8%
Asthenopia
8%
Dental caries
8%
Proctalgia
8%
Abscess limb
8%
Hyperuricaemia
8%
Musculoskeletal chest pain
8%
Malignant melanoma
8%
Fall
8%
Blood creatinine increased
8%
Gamma-glutamyltransferase increased
8%
Procedural pain
8%
Basal cell carcinoma
8%
Haemothorax
8%
Abdominal distension
8%
Lower respiratory tract infection
8%
Skin infection
8%
Urinary tract infection viral
8%
Arthropod bite
8%
Hypoglycaemia
8%
Squamous cell carcinoma of skin
8%
Dyspnoea exertional
8%
Skin ulcer
8%
Hypotension
8%
Dizziness
8%
Cough
8%
Rhinorrhoea
8%
Infusion related reaction
8%
Lower respiratory tract infection viral
8%
Atrial flutter
8%
Hyperparathyroidism secondary
8%
Iron deficiency
8%
Syncope
8%
Skin disorder
8%
Dyspnoea
8%
Urinary tract infection
8%
Lethargy
8%
COVID-19 pneumonia
8%
Cellulitis
8%
Autonomic neuropathy
8%
Large intestine polyp
8%
Loose tooth
8%
Bacterial disease carrier
8%
Folliculitis
8%
Oral candidiasis
8%
Upper respiratory tract infection
8%
Corneal abrasion
8%
Blood alkaline phosphatase increased
8%
Intraocular pressure increased
8%
Hypophosphataemia
8%
Headache
8%
Paraesthesia
8%
Peripheral sensory neuropathy
8%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Belantamab Mafodotin 1.9 mg/kg 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

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
2,999 Previous Clinical Trials
1,794,098 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
~17 spots leftby Feb 2027