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Monoclonal Antibodies
Belantamab Mafodotin + Pd vs Bortezomib + Pd for Multiple Myeloma (DREAMM 8 Trial)
Phase 3
Recruiting
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 including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy.
All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be ≤Grade 1 at the time of enrolment, except for alopecia
Must not have
Presence of active renal conditions
Received prior Beta cell maturation antigen (BCMA) targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 84 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare two different combinations of drugs to see which is more effective in treating relapsed or refractory multiple myeloma.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had at least one prior therapy including lenalidomide, and have measurable disease. They must be in relatively good health (ECOG 0-2), possibly post-autologous stem cell transplant, and not have severe ongoing side effects from previous treatments. Excluded are those with certain infections, unstable liver or kidney conditions, recent heart issues or thromboembolism, active bleeding disorders, other cancers unless stable for 2 years, hypersensitivity to trial drugs or their components.
What is being tested?
The trial is testing the effectiveness of belantamab mafodotin combined with pomalidomide and dexamethasone against a combination of pomalidomide, bortezomib and dexamethasone in treating multiple myeloma that has come back or didn't respond to treatment.
What are the potential side effects?
Potential side effects include eye problems like blurry vision (belantamab mafodotin specific), blood clots due to anti-thrombotic prophylaxis requirements, nerve damage potentially causing pain or numbness (peripheral neuropathy), increased risk of infection due to immune system suppression by the drugs used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one treatment for my multiple myeloma, including a regimen with lenalidomide, and my disease has progressed after the most recent treatment.
Select...
All my side effects from previous cancer treatments are mild, except for hair loss.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with multiple myeloma according to IMWG criteria.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
All my side effects from previous cancer treatments are mild, except for hair loss.
Select...
I had a stem cell transplant over 100 days ago or can't have one, and I don't have any active infections.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an ongoing kidney condition.
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I have received treatment targeting BCMA before.
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I have not undergone plasmapheresis within the last week.
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I do not have cirrhosis or current liver problems.
Select...
I have ongoing nerve pain in my hands or feet, or severe nerve damage.
Select...
I am not allergic to belantamab mafodotin or similar drugs.
Select...
I haven't taken any myeloma treatment or monoclonal antibody drugs recently.
Select...
I have had blood clots in my veins or arteries in the last 3 months.
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I cannot or do not want to take blood clot prevention medication as required by the study.
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I have taken pomalidomide before or cannot tolerate it.
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I have a mild eye condition but no serious corneal disease.
Select...
I am currently experiencing bleeding from an internal organ or mucosa.
Select...
I do not have active HIV, hepatitis B, or hepatitis C, or I meet specific criteria if I do.
Select...
I do not have active plasma cell leukemia, amyloidosis, POEMS syndrome, or related conditions.
Select...
I have had a stem cell transplant from a donor.
Select...
I am currently being treated for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 84 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 84 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Change from Baseline in HRQoL as measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20)
Change from Baseline in HRQoL as measured by EORTC item library 52 (IL52)
Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)
+11 moreSide effects data
From 2024 Phase 1 & 2 trial • 153 Patients • NCT0354428175%
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Belantamab mafodotin plus Pomalidomide and DexamethasoneExperimental Treatment3 Interventions
Group II: Arm B: Bortezomib plus Pomalidomide and DexamethasoneActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1060
Dexamethasone
2007
Completed Phase 4
~2650
Belantamab mafodotin
2022
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,213 Total Patients Enrolled
49 Trials studying Multiple Myeloma
6,445 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,107 Total Patients Enrolled
26 Trials studying Multiple Myeloma
2,896 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing kidney condition.I have received treatment targeting BCMA before.I have not undergone plasmapheresis within the last week.My organs are functioning well.I have had cancer before, but it has been stable for 2 years or I am not on active treatment except for hormonal therapy.I do not have cirrhosis or current liver problems.I have ongoing nerve pain in my hands or feet, or severe nerve damage.I am not allergic to belantamab mafodotin or similar drugs.I haven't taken any myeloma treatment or monoclonal antibody drugs recently.I can sign and understand the consent form.I have had at least one treatment for my multiple myeloma, including a regimen with lenalidomide, and my disease has progressed after the most recent treatment.All my side effects from previous cancer treatments are mild, except for hair loss.I am 18 years old or older.I have heart problems like recent heart attacks, severe heart failure, or uncontrolled high blood pressure.I agree to follow the study's birth control rules.I have had blood clots in my veins or arteries in the last 3 months.I cannot or do not want to take blood clot prevention medication as required by the study.I have taken pomalidomide before or cannot tolerate it.I have a mild eye condition but no serious corneal disease.I am currently experiencing bleeding from an internal organ or mucosa.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I do not have active HIV, hepatitis B, or hepatitis C, or I meet specific criteria if I do.I have been diagnosed with multiple myeloma according to IMWG criteria.I have had at least one treatment for my multiple myeloma, including a regimen with lenalidomide, and my disease has progressed after the most recent treatment.You need to have at least one part of the disease that can be measured.I can take care of myself and am up and about more than half of my waking hours.All my side effects from previous cancer treatments are mild, except for hair loss.I had a stem cell transplant over 100 days ago or can't have one, and I don't have any active infections.I do not have active plasma cell leukemia, amyloidosis, POEMS syndrome, or related conditions.I have had a stem cell transplant from a donor.I am currently being treated for an infection.I have had a stem cell transplant or am not eligible for one.You must have certain levels of proteins in your urine or blood to be eligible.I cannot tolerate bortezomib or my condition worsened during or soon after bortezomib treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
- Group 2: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.