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Monoclonal Antibodies

Belantamab Mafodotin vs. Daratumumab for Multiple Myeloma (DREAMM 7 Trial)

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria
Must have at least 1 aspect of measurable disease, defined as one of the following: Urine M-protein excretion >=200 mg per 24-hour, Serum M-protein concentration >=0.5 grams per deciliter (g/dL), Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65)
Must not have
Prior allogenic stem cell transplant
Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 73 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing two different treatments for relapsed myeloma. One is the standard of care, daratumumab + bortezomib/dexamethasone, and the other is a new drug, belantamab mafodotin, + bortezomib/dexamethasone. The trial will evaluate how well each works and if one is better than the other.

Who is the study for?
This trial is for people with multiple myeloma who've had at least one prior treatment and whose disease has gotten worse after their most recent therapy. They must have good organ function, a performance status showing they can handle daily activities, and measurable signs of the disease. People with eye diseases affecting the cornea, intolerance to certain drugs used in this study, ongoing severe nerve pain or damage, previous treatments targeting BCMA or an allogenic stem cell transplant cannot join.
What is being tested?
The study compares two combinations of cancer drugs in patients with relapsed multiple myeloma: Belantamab Mafodotin with Bortezomib/Dexamethasone versus Daratumumab with Bortezomib/Dexamethasone. It's randomized and open-label so participants know which treatment they're getting.
What are the potential side effects?
Possible side effects include eye problems like blurry vision due to belantamab mafodotin; infections, fatigue, nausea from bortezomib; infusion reactions from daratumumab; and weight gain or mood changes from dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple myeloma according to IMWG standards.
Select...
My cancer can be measured by specific blood or urine tests.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My multiple myeloma has worsened despite having at least one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stem cell transplant from a donor.
Select...
I have ongoing nerve pain or damage that affects my daily activities.
Select...
I have previously received anti-BCMA therapy.
Select...
I have a disease affecting the outer layer of my eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 73 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 73 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
Progression-free Survival (PFS)
Secondary study objectives
Change From Baseline in HRQoL as Measured by EORTC IL52
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
Clinical Benefit Rate (CBR)
+18 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
50%
Thrombocytopenia
45%
Anaemia
39%
Nausea
29%
Decreased appetite
29%
Diarrhoea
27%
Weight decreased
24%
Neuropathy peripheral
24%
Vomiting
23%
Fatigue
21%
Neutropenia
21%
Cataract
15%
Asthenia
12%
Upper respiratory tract infection
11%
Pyrexia
11%
Constipation
8%
Oedema peripheral
8%
Pneumonia
6%
Lymphopenia
6%
Dizziness
6%
Insomnia
6%
Dehydration
6%
Back pain
6%
Leukopenia
6%
Bronchitis
6%
Cough
5%
Acute kidney injury
5%
Abdominal pain
5%
Muscular weakness
5%
Lower respiratory tract infection
3%
Pain in extremity
3%
Sepsis
3%
Hyperglycaemia
3%
Urinary tract infection
3%
Nasopharyngitis
3%
Hyponatraemia
3%
Toothache
3%
Disturbance in attention
3%
Cardiac failure
3%
Hypertension
2%
Blood uric acid increased
2%
Cardiac failure acute
2%
Pulmonary contusion
2%
Peripheral swelling
2%
Blood creatinine increased
2%
Paraesthesia
2%
Infection
2%
Respiratory syncytial virus infection
2%
Dyspepsia
2%
Syncope
2%
Clostridium difficile infection
2%
Compression fracture
2%
Multiple fractures
2%
Myocardial infarction
2%
C-reactive protein increased
2%
Cerebral haemorrhage
2%
Ischaemic stroke
2%
Sudden death
2%
Oropharyngeal pain
2%
Cognitive disorder
2%
Confusional state
2%
Influenza
2%
Septic shock
2%
Osteonecrosis of jaw
2%
Taste disorder
2%
Hyperkalaemia
2%
Depression
2%
Cerebrovascular accident
2%
Bronchitis viral
2%
Embolism
2%
Haemoglobin decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SdX Arm: Selinexor + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

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: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)Experimental Treatment3 Interventions
Group II: Daratumumab and Bortezomib plus Dexamethasone (Arm B)Active Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2022
Completed Phase 2
~240
Bortezomib
2005
Completed Phase 3
~1410
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,076 Total Patients Enrolled
49 Trials studying Multiple Myeloma
6,308 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,144,970 Total Patients Enrolled
26 Trials studying Multiple Myeloma
2,759 Patients Enrolled for Multiple Myeloma

Media Library

Belantamab Mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04246047 — Phase 3
Multiple Myeloma Research Study Groups: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A), Daratumumab and Bortezomib plus Dexamethasone (Arm B)
Multiple Myeloma Clinical Trial 2023: Belantamab Mafodotin Highlights & Side Effects. Trial Name: NCT04246047 — Phase 3
Belantamab Mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246047 — Phase 3
~88 spots leftby Dec 2025
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