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Antibody-drug Conjugate

Belantamab Mafodotin Combinations for Multiple Myeloma (DREAMM 6 Trial)

East Setauket, NY
Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy
Have undergone stem cell transplant (SCT), or are considered transplant ineligible
Must not have
Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension
Current corneal disease except for mild punctute keratopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new drug, belantamab mafodotin, when used in combination with either Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone, in patients with RRMM who have relapsed or are refractory to at least one line of approved therapy.

See full description
Who is the study for?
Adults with relapsed/refractory Multiple Myeloma who've had at least one prior treatment can join this trial. They must have measurable disease, be in good physical condition (ECOG 0-1 for Arm A, ECOG 0-2 for Arm B), and not have severe organ damage or active infections. Women of childbearing potential must use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of GSK2857916 combined with Lenalidomide plus Dexamethasone (Arm A) or Bortezomib plus Dexamethasone (Arm B). It has two parts: dose escalation to find a safe dosage and then further evaluation of that dosage's clinical activity.See study design
What are the potential side effects?
Possible side effects include eye problems, infusion reactions, blood disorders, fatigue, infection risk increase, and organ inflammation. Specific side effects may depend on whether patients are in Arm A or Arm B due to different combination therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma has worsened despite having at least one treatment.
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I have had a stem cell transplant or am not eligible for one.
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I have been diagnosed with Multiple Myeloma.
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I am not pregnant, can test before treatment, and will use birth control during and after the study.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart problems like uncontrolled high blood pressure or recent heart attacks.
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I have a mild eye condition but no serious corneal disease.
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I haven't taken any experimental drugs recently.
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I haven't had any myeloma treatment or plasmapheresis in the last 2 weeks.
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I am currently experiencing bleeding from an internal organ or mucosa.
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I have a mild eye condition but no serious corneal disease.
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I am currently being treated for an infection.
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I am HIV positive.
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I can tolerate blood clot prevention medication and have not stopped lenalidomide due to side effects.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Urine Potential of Hydrogen (pH)
Change From Baseline in Urine Specific Gravity
Change From Baseline in Vital Signs : Pulse Rate
+12 more
Secondary study objectives
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B
AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B
+66 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

2Treatment groups
Experimental Treatment
Group I: Arm B: Belantamab mafodotin+bortezomib+dexamethasoneExperimental Treatment3 Interventions
Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 \& 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 \& 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 \& so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, \& so on). Bortezomib will be administered at 1.3 mg/m\^2 SC/IV on Days 1,4,8, \& 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, \& 12 of every 21-day cycle.
Group II: Arm A: Belantamab mafodotin+lenalidomide +dexamethasoneExperimental Treatment3 Interventions
Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion. SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle. STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, \& 22 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Dexamethasone
2007
Completed Phase 4
~2650
Bortezomib
2005
Completed Phase 3
~1410
Belantamab mafodotin
2022
Completed Phase 2
~240

Find a Location

Closest Location:GSK Investigational Site· Indianapolis, IN· 168 miles

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,828 Previous Clinical Trials
8,387,254 Total Patients Enrolled
49 Trials studying Multiple Myeloma
6,269 Patients Enrolled for Multiple Myeloma
Iqvia Pty LtdIndustry Sponsor
119 Previous Clinical Trials
176,677 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,610 Previous Clinical Trials
6,146,415 Total Patients Enrolled
26 Trials studying Multiple Myeloma
2,845 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab mafodotin (Antibody-drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03544281 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Arm B: Belantamab mafodotin+bortezomib+dexamethasone, Arm A: Belantamab mafodotin+lenalidomide +dexamethasone
Multiple Myeloma Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT03544281 — Phase 1 & 2
Belantamab mafodotin (Antibody-drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03544281 — Phase 1 & 2
~21 spots leftby Mar 2026