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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
DREAMM5 Trial 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.Check my eligibility
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.See study design
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.
DREAMM5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking low-dose oral steroids, inhaled steroids, or eye steroids.
Select...
I have had 3 or more treatments for myeloma, including specific types of therapy.
Select...
My platelet count is at least 75,000 per microliter.
Select...
I have been diagnosed with Multiple Myeloma according to IMWG standards.
DREAMM5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreSide effects data
From 2022 Phase 1 trial • 6 Patients • NCT0417782367%
Blood lactate dehydrogenase increased
67%
Lymphocyte count decreased
67%
Platelet count decreased
67%
Hyponatraemia
50%
Hypocalcaemia
50%
White blood cell count decreased
50%
Aspartate aminotransferase increased
50%
Neutrophil count decreased
50%
Hyperphosphataemia
50%
Pyrexia
33%
Alanine aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Hypercalcaemia
33%
Hyperuricaemia
33%
Hypokalaemia
33%
Hypomagnesaemia
33%
Punctate keratitis
33%
Vision blurred
17%
Hyperglycaemia
17%
Myelosuppression
17%
Liver injury
17%
Adenosine deaminase increased
17%
Alpha hydroxybutyrate dehydrogenase increased
17%
Glycocholic acid increased
17%
Protein total decreased
17%
Crystal urine present
17%
Gamma-glutamyltransferase increased
17%
Leucine aminopeptidase increased
17%
Lymphocyte count increased
17%
Prealbumin decreased
17%
Total bile acids increased
17%
Urinary occult blood
17%
Visual impairment
17%
Leukocytosis
17%
Thrombocytopenia
17%
Mouth ulceration
17%
Lung disorder
17%
Hypertension
17%
Electrocardiogram QT prolonged
17%
Trigeminal neuralgia
17%
Purpura
17%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin
DREAMM5 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
Dostarlimab
2020
Completed Phase 2
~1000
Pomalidomide
2011
Completed Phase 2
~1020
GSK3174998
2015
Completed Phase 1
~1030
Isatuximab
2016
Completed Phase 3
~370
Lenalidomide
2005
Completed Phase 3
~1480
Belantamab mafodotin
2019
Completed Phase 1
~10
Feladilimab
2019
Completed Phase 2
~110
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,352 Total Patients Enrolled
47 Trials studying Multiple Myeloma
5,969 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,466 Total Patients Enrolled
25 Trials studying Multiple Myeloma
2,940 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received CAR-T therapy with chemotherapy less than 3 months ago.I stopped a previous cancer treatment due to severe side effects.I have low levels of phosphate, potassium, or magnesium that don't improve with treatment.I have not had radiotherapy in the last 2 weeks.I haven't taken anti-CD38 drugs in the last 6 months.I cannot or do not want to take blood clot prevention medication as required.I have an immune system disorder or have been on immune-weakening medication recently, except for inhaled or local steroids.I tested positive for Hepatitis B core antibody but do not have active Hepatitis B.I am currently taking low-dose oral steroids, inhaled steroids, or eye steroids.You have a known allergy or bad reaction to certain protein products, sucrose, histidine, or polysorbate 80.I have a kidney condition that could affect my safety in the trial, but protein in my urine is due to my multiple myeloma.I am not taking strong HIV drugs that affect liver enzymes if I am to receive nirogacestat.I have been treated with a gamma secretase inhibitor before.I have an autoimmune disease and have received systemic treatment in the last 2 years.I have an uncontrolled intestinal condition.I have no severe allergies to belantamab mafodotin or similar drugs.I am currently on treatment for an active infection.I have had 3 or more treatments for myeloma, including specific types of therapy.I can care for myself but may not be able to do heavy physical work, except if my limitations are due to bone issues from my multiple myeloma.I haven't taken any monoclonal antibodies or systemic anti-myeloma treatments in the last 30 days.I have been diagnosed with interstitial lung disease.I had a stem cell transplant over 100 days ago and currently have no infections.I have HIV under control with treatment, no recent severe infections, and good immune health.You need to have certain levels of M-protein or urine protein, or a specific ratio of free light chains in your blood, to be eligible.I haven't had any live vaccines in the last 30 days and won't during or for 70 days after the trial.I stopped taking pomalidomide because of severe side effects.I have an autoimmune disease treated with medication in the last 2 years.You have a severe allergy to Isatuximab-irfc or any of its ingredients.I have had a blood clot in the past 3 months.I am currently experiencing bleeding from internal organs or mucous membranes.I am not taking strong drugs that affect liver enzyme CYP3A4.I am 18 years old or older.I have a mild eye condition but no serious corneal disease.I am at risk for heart disease.My platelet count is at least 75,000 per microliter.I have a skin condition that is not under control.I have been diagnosed with Multiple Myeloma according to IMWG standards.I have not had major surgery in the last 30 days, except for bone-stabilizing surgery.I have not received any blood transfusions in the last 2 weeks.I have not had symptoms of pericarditis in the last 6 months.I have previously been treated with drugs targeting PD-1 or PD-L1/PD-L2.I stopped taking lenalidomide because of severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)
- Group 2: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)
- Group 3: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)
- Group 4: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)
- Group 5: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8)
- Group 6: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)
- Group 7: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)
- Group 8: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)
- Group 9: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)
- Group 10: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)
- Group 11: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)
- Group 12: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)
- Group 13: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)
- Group 14: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8)
- Group 15: Belantamab mafodotin monotherapy cohort expansion
- Group 16: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)
- Group 17: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical trial for new patients seeking treatment?
"This study, as detailed on clinicaltrials.gov, is still recruiting patients. The listing for this trial was created on October 7th, 2019 and updated September 23rd, 2020."
Answered by AI
Are there other ongoing research projects studying Belantamab mafodotin?
"City of Hope first studied belantamab mafodotin in 2010 and since then 722 additional studies have completed. As of now, 125 studies are ongoing with a large number hosted in Atlanta, Georgia."
Answered by AI
How many people are allowed to be a part of this research at one time?
"Yes, this clinical trial is still actively recruiting patients according to the information posted on clinicaltrials.gov. 464 individuals are needed for the study which started on October 7th, 2019 and was most recently edited on September 23rd, 2020. There are 9 locations where recruitment is taking place."
Answered by AI
What is Belantamab mafodotin's main area of focus?
"Belantamab mafodotin is used to treat relapsed or refractory multiple myeloma, as well as disease progression during or after platinum-containing chemotherapy."
Answered by AI
What is the purpose of this clinical trial?
"The primary outcome being measured in this study, which will last up to 36 months, is the number of participants that experience dose limiting toxicities. Additionally, this clinical trial will also be evaluating secondary outcomes including the number of patients with adverse events and the concentration of ADAs when administered with belantamab mafodotin."
Answered by AI
Recent research and studies
Current Hematologic Malignancy ReportsJournal
Antibody-based Treatment Approaches in Multiple MyelomaOther Trials to Consider
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