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Monoclonal Antibodies

Belantamab Mafodotin Combinations for Multiple Myeloma (DREAMM5 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmalogical steroids.
Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Must not have
Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the side effects of an antibody-drug conjugate called belantamab mafodotin when given with other anti-cancer drugs to people with relapsed or refractory multiple myeloma.

Who is the study for?
Adults with a confirmed diagnosis of Multiple Myeloma who have tried at least three prior treatments, including an immunomodulating agent and a proteasome inhibitor. They must have measurable disease, be in good physical condition (ECOG 0-1), and not have had certain recent treatments or uncontrolled diseases. Specific criteria apply for participants from Japan and China.
What is being tested?
The trial is testing Belantamab Mafodotin alone or combined with other anti-cancer drugs in those with relapsed/refractory Multiple Myeloma. It's an open-label study where different drug combinations are tested simultaneously to see how well they work.
What are the potential side effects?
Potential side effects include reactions related to the immune system, skin conditions, changes in blood chemistry like low phosphate/potassium/magnesium levels, eye problems such as corneal disease, increased risk of infections, and possible hypersensitivity to the treatment components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently taking low-dose oral steroids, inhaled steroids, or eye steroids.
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I have had 3 or more treatments for myeloma, including specific types of therapy.
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My platelet count is at least 75,000 per microliter.
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I have been diagnosed with Multiple Myeloma according to IMWG standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I received CAR-T therapy with chemotherapy less than 3 months ago.
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I stopped a previous cancer treatment due to severe side effects.
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I have low levels of phosphate, potassium, or magnesium that don't improve with treatment.
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I have not had radiotherapy in the last 2 weeks.
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I cannot or do not want to take blood clot prevention medication as required.
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I have a kidney condition that could affect my safety in the trial, but protein in my urine is due to my multiple myeloma.
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I have been treated with a gamma secretase inhibitor before.
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I have an autoimmune disease and have received systemic treatment in the last 2 years.
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I have an uncontrolled intestinal condition.
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I am currently on treatment for an active infection.
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I have been diagnosed with interstitial lung disease.
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I haven't had any live vaccines in the last 30 days and won't during or for 70 days after the trial.
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I stopped taking pomalidomide because of severe side effects.
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I have had a blood clot in the past 3 months.
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I am currently experiencing bleeding from internal organs or mucous membranes.
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I am not taking strong drugs that affect liver enzyme CYP3A4.
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I have a mild eye condition but no serious corneal disease.
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I have a skin condition that is not under control.
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I have previously been treated with drugs targeting PD-1 or PD-L1/PD-L2.
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I stopped taking lenalidomide because of severe side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
CE Phase: Number of participants achieving Overall Response Rate (ORR)
DE Phase: Number of participants achieving dose limiting toxicities (DLT)
DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
+1 more
Secondary study objectives
CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments
CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin
CE Phase: Concentration of ADAs against belantamab mafodotin when administered in combination with anti-cancer treatments
+51 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
8%
Inguinal hernia
8%
Hypertension
8%
Cellulitis
8%
Pseudomonas infection
8%
Septic shock
8%
Acute myocardial infarction
8%
Cardiac failure congestive
8%
Colitis
8%
Pyrexia
8%
Tricuspid valve incompetence
8%
Lymphopenia
8%
Thrombocytopenia
8%
Cardiac failure
8%
Mitral valve incompetence
8%
Asthenopia
8%
Blepharitis
8%
Blepharospasm
8%
Cataract
8%
Cataract cortical
8%
Dry eye
8%
Eye irritation
8%
Eye pain
8%
Squamous cell carcinoma of skin
8%
Meibomian gland dysfunction
8%
Gastrooesophageal reflux disease
8%
Haemorrhoids
8%
Balance disorder
8%
Paraesthesia oral
8%
Asthenia
8%
Feeling abnormal
8%
Oedema
8%
Hypertransaminasaemia
8%
Gastroenteritis
8%
Nail infection
8%
Nasopharyngitis
8%
Oral candidiasis
8%
Respiratory tract infection
8%
Viral infection
8%
Chemical burns of eye
8%
Contusion
8%
Blood alkaline phosphatase increased
8%
Weight decreased
8%
Hyperglycaemia
8%
Hypertriglyceridaemia
8%
Hypocalcaemia
8%
Hypokalaemia
8%
Hypomagnesaemia
8%
Hypophosphataemia
8%
Bone pain
8%
Bursitis
8%
Myalgia
8%
Lethargy
8%
Paraesthesia
8%
Peripheral sensory neuropathy
8%
Restless legs syndrome
8%
Tremor
8%
Delirium
8%
Acute kidney injury
8%
Urinary incontinence
8%
Vulvovaginal pruritus
8%
Dyspnoea
8%
Dyspnoea exertional
8%
Epistaxis
8%
Haemoptysis
8%
Oropharyngeal discomfort
8%
Blister
8%
Cold urticaria
100%
80%
60%
40%
20%
0%
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

17Treatment groups
Experimental Treatment
Active Control
Group I: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)Experimental Treatment2 Interventions
Group II: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)Experimental Treatment2 Interventions
Group III: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)Experimental Treatment2 Interventions
Group IV: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)Experimental Treatment2 Interventions
Group V: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)Experimental Treatment2 Interventions
Group VI: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)Experimental Treatment2 Interventions
Group VII: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)Experimental Treatment4 Interventions
Group VIII: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)Experimental Treatment4 Interventions
Group IX: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8)Experimental Treatment4 Interventions
This cohort will enroll Northeast Asian participants.
Group X: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)Experimental Treatment4 Interventions
Group XI: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8)Experimental Treatment4 Interventions
This cohort will enroll Northeast Asian participants.
Group XII: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)Experimental Treatment4 Interventions
Group XIII: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)Experimental Treatment2 Interventions
Group XIV: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)Experimental Treatment2 Interventions
Group XV: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)Experimental Treatment2 Interventions
Group XVI: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)Experimental Treatment2 Interventions
Group XVII: Belantamab mafodotin monotherapy cohort expansionActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3174998
2015
Completed Phase 1
~1030
Dostarlimab
2019
Completed Phase 3
~2180
Pomalidomide
2011
Completed Phase 2
~1060
Isatuximab
2016
Completed Phase 3
~370
Lenalidomide
2005
Completed Phase 3
~2240
Belantamab mafodotin
2022
Completed Phase 2
~240
Feladilimab
2019
Completed Phase 2
~290
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,106 Total Patients Enrolled
49 Trials studying Multiple Myeloma
6,338 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,000 Total Patients Enrolled
26 Trials studying Multiple Myeloma
2,789 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04126200 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7), Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8), Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4), Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6), Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6), Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3), Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1), Belantamab mafodotin+feladilimab dose exploration (Sub-study 2), Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3), Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4), Belantamab mafodotin+isatuximab dose exploration (Sub-study 5), Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7), Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5), Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8), Belantamab mafodotin monotherapy cohort expansion, Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1), Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT04126200 — Phase 1 & 2
Belantamab mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04126200 — Phase 1 & 2
~85 spots leftby Feb 2026
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