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Monoclonal Antibodies

Belantamab Mafodotin for Multiple Myeloma

Phase 2
Recruiting
Led By Adam Cohen, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible by institutional criteria to receive melphalan at a dose of 200 mg/m2.
Have received no more than 2 prior lines of induction therapy (induction regimen not specified by protocol), with no prior progressive disease by International Myeloma Working Group (IMWG) criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug, given with standard treatment, to see if it is safe and works better than the standard treatment alone.

Who is the study for?
This trial is for adults with multiple myeloma who've had no more than two prior treatments, are not in complete remission but have responded to therapy, and can undergo high-dose chemotherapy and stem cell transplant. They must be able to take maintenance therapy post-transplant and have good organ function. Pregnant or breastfeeding individuals, those with certain heart risks, infections needing antibiotics, other cancers (except if stable/treated), major surgery within the last month, active hepatitis B/C or HIV cannot join.Check my eligibility
What is being tested?
The study tests Belantamab Mafodotin as an additional treatment before and after autologous stem cell transplant in multiple myeloma patients. It's given alongside standard melphalan chemotherapy pre-transplant and lenalidomide maintenance post-transplant. The goal is to see if this approach is safe and improves outcomes compared to past data.See study design
What are the potential side effects?
Belantamab Mafodotin may cause vision issues like blurry eyesight due to effects on the cornea, bone marrow suppression leading to low blood counts which increases infection risk, fatigue, nausea or vomiting from chemo drugs used during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am approved to receive a specific chemotherapy dose.
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I've had up to 2 initial treatments for my condition without worsening.
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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 am eligible for lenalidomide treatment after my stem cell transplant.
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My cancer has partially responded to treatment, but is not completely gone after 4 treatment cycles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MRD (minimal residual disease) negativity rate
Secondary outcome measures
Change from Baseline in Health-related quality of life (HRQoL) as assessed by Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire
Complete response (CR) or better rate
Dose delays
+10 more

Side effects data

From 2024 Phase 1 & 2 trial • 153 Patients • NCT03544281
83%
Keratopathy
67%
Vision blurred
50%
Upper respiratory tract infection
50%
Platelet count decreased
44%
Diarrhoea
44%
Nausea
33%
Thrombocytopenia
33%
Photophobia
33%
Fatigue
33%
Constipation
33%
Insomnia
33%
Neuropathy peripheral
28%
Decreased appetite
28%
Back pain
22%
Anaemia
22%
Eye pain
22%
Contusion
22%
Hypertension
22%
Peripheral sensory neuropathy
22%
Dry eye
17%
Productive cough
17%
Dyspepsia
17%
Vomiting
17%
Weight increased
17%
Hypokalaemia
17%
Oropharyngeal pain
17%
Punctate keratitis
17%
Oedema peripheral
17%
Arthralgia
17%
Cough
11%
Sinus bradycardia
11%
Aspartate aminotransferase increased
11%
Non-cardiac chest pain
11%
Pneumonia
11%
Blepharitis
11%
Conjunctivitis
11%
Lower respiratory tract infection
11%
Fall
11%
Visual acuity tests abnormal
11%
Pain in extremity
11%
Dyspnoea
11%
Dysphagia
11%
Bursitis
11%
Dizziness
11%
Epistaxis
11%
Stomatitis
11%
Pyrexia
11%
Rhinitis
11%
Urinary tract infection
11%
Weight decreased
11%
Haematoma
11%
Dysgeusia
11%
Neuralgia
11%
Cataract cortical
11%
Meibomian gland dysfunction
11%
Influenza
11%
Neutrophil count decreased
11%
Viral upper respiratory tract infection
11%
Muscular weakness
11%
Headache
11%
Depression
11%
Neutropenia
11%
Chalazion
11%
Visual acuity reduced
11%
Hyponatraemia
11%
Anxiety
6%
Atrial fibrillation
6%
Dehydration
6%
Hyperuricaemia
6%
Ilium fracture
6%
Tinea pedis
6%
Pulmonary oedema
6%
Bone pain
6%
Myocardial infarction
6%
Thyroid mass
6%
Corneal oedema
6%
Occult blood positive
6%
Coronavirus infection
6%
Folate deficiency
6%
Abscess
6%
Faecaloma
6%
Hypercalcaemia
6%
Swelling
6%
Conjunctivitis bacterial
6%
Gastrointestinal infection
6%
Respiratory tract infection
6%
Blood lactate dehydrogenase increased
6%
Infusion related reaction
6%
Proteinuria
6%
Squamous cell carcinoma
6%
Autonomic neuropathy
6%
Pericardial effusion
6%
Conjunctival hyperaemia
6%
Blindness unilateral
6%
Conjunctival haemorrhage
6%
Retinal haemorrhage
6%
Gastrooesophageal reflux disease
6%
Hyperaesthesia teeth
6%
Chills
6%
Injection site reaction
6%
Localised oedema
6%
Mucosal inflammation
6%
Nosocomial infection
6%
Phlebitis
6%
Rhinovirus infection
6%
Alanine aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Glucose tolerance impaired
6%
Bone cyst
6%
Groin pain
6%
Tendon disorder
6%
Radiculopathy
6%
Agitation
6%
Irritability
6%
Urinary hesitation
6%
Haemoptysis
6%
Infection
6%
Upper gastrointestinal haemorrhage
6%
Eczema
6%
Dysuria
6%
Corneal opacity
6%
Diplopia
6%
Retinal vein occlusion
6%
Alopecia
6%
Dermatitis acneiform
6%
Visual impairment
6%
Abdominal pain upper
6%
Diverticulum
6%
Dry mouth
6%
Oedema
6%
Peripheral swelling
6%
Enterovirus infection
6%
Escherichia urinary tract infection
6%
Tendon rupture
6%
Urine output decreased
6%
Diffuse idiopathic skeletal hyperostosis
6%
Pruritus
6%
Rash maculo-papular
6%
Pelvic pain
6%
Osteoarthritis
6%
Deep vein thrombosis
6%
Sciatica
6%
Iron deficiency anaemia
6%
Leukocytosis
6%
Hypoacusis
6%
Asthenopia
6%
Cataract subcapsular
6%
Cellulitis
6%
Sternal fracture
6%
Ventricular arrhythmia
6%
Ear haemorrhage
6%
Abdominal distension
6%
Catheter site bruise
6%
Chest pain
6%
Hypogammaglobulinaemia
6%
Bronchitis
6%
Bone contusion
6%
Hyperglycaemia
6%
Exposed bone in jaw
6%
Haematuria
6%
Urinary incontinence
6%
Urinary retention
6%
Pleuritic pain
6%
Pneumocystis jirovecii pneumonia
6%
Sepsis
6%
Lower limb fracture
6%
Pathological fracture
6%
Syncope
6%
Cytopenia
6%
Palpitations
6%
Ventricular hypokinesia
6%
Foreign body sensation in eyes
6%
Glaucoma
6%
Gastrointestinal haemorrhage
6%
Cardiac arrest
6%
Cataract
6%
Night blindness
6%
Colitis microscopic
6%
Irritable bowel syndrome
6%
Facial pain
6%
Gastroenteritis
6%
Herpes simplex reactivation
6%
Prostate infection
6%
Blood cholesterol increased
6%
Blood creatine phosphokinase increased
6%
Electrocardiogram QT prolonged
6%
Glycosylated haemoglobin increased
6%
Arthritis
6%
Nasal congestion
6%
Rhinorrhoea
6%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belantamab mafodotinExperimental Treatment1 Intervention
Patients receive Belantamab mafodotin 2.5 mg/kg by intravenous infusion on day -42 relative to autologous stem cell infusion (day 0), on day +60, and every 90 days thereafter, for up to 2 years following ASCT.
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?

University of PennsylvaniaLead Sponsor
2,018 Previous Clinical Trials
42,874,075 Total Patients Enrolled
13 Trials studying Multiple Myeloma
332 Patients Enrolled for Multiple Myeloma
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,951 Total Patients Enrolled
7 Trials studying Multiple Myeloma
213 Patients Enrolled for Multiple Myeloma
Abramson Cancer Center at Penn MedicineLead Sponsor
390 Previous Clinical Trials
145,884 Total Patients Enrolled
8 Trials studying Multiple Myeloma
288 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04680468 — Phase 2
Multiple Myeloma Research Study Groups: Belantamab mafodotin
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT04680468 — Phase 2
Belantamab mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04680468 — Phase 2
~19 spots leftby Jul 2026
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