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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 84 months
Awards & highlights
DREAMM 8 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.Check my eligibility
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.See study design
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.
DREAMM 8 Trial 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.
DREAMM 8 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for pomalidomide
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)
+21 moreSide effects data
From 2022 Phase 1 trial • 6 Patients • NCT0417782367%
Platelet count decreased
67%
Blood lactate dehydrogenase increased
67%
Lymphocyte 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%
Myelosuppression
17%
Liver injury
17%
Adenosine deaminase increased
17%
Blood creatine phosphokinase increased
17%
Alpha hydroxybutyrate dehydrogenase increased
17%
Electrocardiogram QT prolonged
17%
Glycocholic acid increased
17%
Protein total decreased
17%
Crystal urine present
17%
Gamma-glutamyltransferase increased
17%
Leucine aminopeptidase increased
17%
Hyperglycaemia
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%
Trigeminal neuralgia
17%
Lung disorder
17%
Purpura
17%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin
DREAMM 8 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
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Belantamab mafodotin
2019
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,069,101 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,076 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,573 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,047 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are enrolled in this experiment?
"That is correct. The information available on clinicaltrials.gov does show that this trial is recruiting patients. The trial was posted on October 1st, 2020 and was last updated on October 12th, 2020. They are looking for 300 patients across 15 different locations."
Answered by AI
Are there any vacancies in this clinical experiment for new test subjects?
"Yes, this is an ongoing recruitment effort for a clinical trial that was first posted on October 1st, 2020. The most recent update to the listing was on October 12th, 2022. They are looking for a total of 300 patients, to be enrolled at 15 different locations."
Answered by AI
What condition does Belantamab mafodotin help alleviate?
"ophthalmia, sympathetic is most commonly treated with Belantamab mafodotin. Belantamab mafodotin is also useful for treating other conditions including branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
Are there different hospitals or research centers conducting this experiment in town?
"There are 15 sites enrolling patients in this trial. Major cities offering this medication include New york, Miami, and San Francisco."
Answered by AI
Have there been other research projects that have used Belantamab mafodotin?
"The first documentation of Belantamab mafodotin comes from the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002. As of now, there have been a total of 1412 completed trials and 654 live studies. A significant number of these studies are being conducted in Tucson, Florida."
Answered by AI
When did Belantamab mafodotin receive FDA approval for use?
"Belantamab mafodotin is a Phase 3 medication, so it has received a score of 3 for safety. This means that while there is some data supporting efficacy, there is more data supporting safety."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
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