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Antibody-drug Conjugate
Belantamab Mafodotin Combinations for Multiple Myeloma (DREAMM 6 Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4.5 years
Awards & highlights
DREAMM 6 Trial 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.
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.
DREAMM 6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has worsened despite having at least one treatment.
Select...
I have had a stem cell transplant or am not eligible for one.
Select...
I have been diagnosed with Multiple Myeloma.
Select...
I am not pregnant, can test before treatment, and will use birth control during and after the study.
DREAMM 6 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreSide effects data
From 2024 Phase 1 & 2 trial • 153 Patients • NCT0354428183%
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%
Back pain
28%
Decreased appetite
22%
Anaemia
22%
Eye pain
22%
Contusion
22%
Hypertension
22%
Peripheral sensory neuropathy
22%
Dry eye
17%
Punctate keratitis
17%
Dyspepsia
17%
Vomiting
17%
Oedema peripheral
17%
Weight increased
17%
Hypokalaemia
17%
Oropharyngeal pain
17%
Productive cough
17%
Arthralgia
17%
Cough
11%
Sinus bradycardia
11%
Stomatitis
11%
Non-cardiac chest pain
11%
Pyrexia
11%
Urinary tract infection
11%
Pneumonia
11%
Blepharitis
11%
Dysphagia
11%
Conjunctivitis
11%
Lower respiratory tract infection
11%
Rhinitis
11%
Fall
11%
Visual acuity tests abnormal
11%
Aspartate aminotransferase increased
11%
Weight decreased
11%
Bursitis
11%
Pain in extremity
11%
Epistaxis
11%
Dyspnoea
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%
Dizziness
11%
Headache
11%
Depression
11%
Neutropenia
11%
Chalazion
11%
Visual acuity reduced
11%
Hyponatraemia
11%
Anxiety
6%
Atrial fibrillation
6%
Dehydration
6%
Hypercalcaemia
6%
Hyperuricaemia
6%
Ilium fracture
6%
Pulmonary oedema
6%
Bone pain
6%
Myocardial infarction
6%
Thyroid mass
6%
Corneal oedema
6%
Coronavirus infection
6%
Abscess
6%
Faecaloma
6%
Escherichia urinary tract infection
6%
Retinal vein occlusion
6%
Dry mouth
6%
Swelling
6%
Conjunctivitis bacterial
6%
Gastrointestinal infection
6%
Respiratory tract infection
6%
Blood lactate dehydrogenase increased
6%
Infusion related reaction
6%
Squamous cell carcinoma
6%
Autonomic neuropathy
6%
Pericardial effusion
6%
Conjunctival hyperaemia
6%
Blindness unilateral
6%
Conjunctival haemorrhage
6%
Corneal opacity
6%
Diplopia
6%
Retinal haemorrhage
6%
Visual impairment
6%
Abdominal pain upper
6%
Gastrooesophageal reflux disease
6%
Hyperaesthesia teeth
6%
Chills
6%
Injection site reaction
6%
Localised oedema
6%
Mucosal inflammation
6%
Oedema
6%
Peripheral swelling
6%
Enterovirus infection
6%
Nosocomial infection
6%
Rhinovirus infection
6%
Tendon rupture
6%
Alanine aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Urine output decreased
6%
Glucose tolerance impaired
6%
Bone cyst
6%
Groin pain
6%
Tendon disorder
6%
Radiculopathy
6%
Agitation
6%
Irritability
6%
Dysuria
6%
Urinary hesitation
6%
Haemoptysis
6%
Alopecia
6%
Dermatitis acneiform
6%
Eczema
6%
Pruritus
6%
Rash maculo-papular
6%
Phlebitis
6%
Pelvic pain
6%
Osteoarthritis
6%
Deep vein thrombosis
6%
Upper gastrointestinal haemorrhage
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%
Diverticulum
6%
Catheter site bruise
6%
Chest pain
6%
Hypogammaglobulinaemia
6%
Bronchitis
6%
Tinea pedis
6%
Bone contusion
6%
Hyperglycaemia
6%
Diffuse idiopathic skeletal hyperostosis
6%
Exposed bone in jaw
6%
Haematuria
6%
Urinary incontinence
6%
Urinary retention
6%
Pleuritic pain
6%
Pneumocystis jirovecii pneumonia
6%
Sepsis
6%
Infection
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%
Occult blood positive
6%
Folate deficiency
6%
Arthritis
6%
Proteinuria
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
DREAMM 6 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
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 2
~1070
Bortezomib
2005
Completed Phase 2
~1060
Belantamab mafodotin
2019
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,764 Previous Clinical Trials
8,104,696 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,281 Patients Enrolled for Multiple Myeloma
Iqvia Pty LtdIndustry Sponsor
108 Previous Clinical Trials
171,855 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,188 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,252 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a specific amount of protein in your urine or blood to qualify for the study.You have tested positive for hepatitis C within the last 3 months.My multiple myeloma has worsened despite having at least one treatment.My organs are functioning well according to recent tests.I have tested positive for hepatitis B recently.You have had a bad reaction to drugs similar to belantamab mafodotin or its ingredients.I had a stem cell transplant over 100 days ago and currently have no infections.I had severe side effects from bortezomib, including nerve pain.My side effects from previous cancer treatments are mild, except for hair loss or moderate nerve pain.I agree to follow the study's rules for using contraception and not donating sperm.I have a mild eye condition but no serious corneal disease.I am fully active or restricted in physically strenuous activity but can do light work.I have heart problems like uncontrolled high blood pressure or recent heart attacks.I agree to use effective birth control and have two negative pregnancy tests before starting lenalidomide.I haven't had any myeloma treatment or plasmapheresis in the last 2 weeks.I haven't had monoclonal antibody treatment in the last 30 days.I am currently experiencing bleeding from an internal organ or mucosa.I haven't taken any experimental drugs recently.I had a stem cell transplant from a donor, with no current or past graft versus host disease.I have not had any major surgery in the last four weeks.I have a kidney condition but it's only protein in my urine due to my MM.I have had a stem cell transplant or am not eligible for one.I have a mild eye condition but no serious corneal disease.I have only multiple myeloma or a stable cancer for 2+ years, not under active treatment.I do not have active liver disease, except for Gilbert's syndrome or harmless gallstones.I can sign and understand the consent form.I am 18 years old or older.I have been diagnosed with Multiple Myeloma.I am currently being treated for an infection.I am HIV positive.I can tolerate blood clot prevention medication and have not stopped lenalidomide due to side effects.I am not pregnant or breastfeeding and follow the required contraception guidelines.I am not pregnant, can test before treatment, and will use birth control during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Belantamab mafodotin+bortezomib+dexamethasone
- Group 2: Arm A: Belantamab mafodotin+lenalidomide +dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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