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Monoclonal Antibodies
Belantamab Mafodotin for Multiple Myeloma (DREAMM-3 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
All prior treatment-related toxicities must be <=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy
Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
DREAMM-3 Trial Summary
This trial is testing whether the drug belantamab mafodotin is more effective and has fewer side effects than the standard treatment for relapsed or refractory multiple myeloma.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had at least two prior treatments, including lenalidomide and a proteasome inhibitor, can join. They must have measurable disease levels, adequate organ function, and no major surgery or active infections recently. Pregnant women, those with certain medical conditions or previous BCMA-targeted therapy are excluded.Check my eligibility
What is being tested?
The trial compares belantamab mafodotin (administered every three weeks) against pomalidomide plus low-dose dexamethasone (pomalidomide daily for 21 days of a 28-day cycle; dexamethasone weekly). Participants will be randomly assigned to one of these treatments until their disease progresses or they experience unacceptable side effects.See study design
What are the potential side effects?
Belantamab mafodotin may cause vision issues like blurry eyesight and corneal problems. Pom/dex can lead to weakened immune system responses, increased risk of infections, blood clots, fatigue, bone thinning and mood swings due to steroid use.
DREAMM-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments are mild, except for hair loss and some nerve pain.
Select...
I am at least 18 years old, or over 19 if I am from the Republic of Korea.
Select...
I've had at least 2 treatments for myeloma, including lenalidomide and a proteasome inhibitor, but my disease still progressed.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have multiple myeloma and have had or can't have a stem cell transplant.
DREAMM-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 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) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG)
Secondary outcome measures
Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)
Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein (Grams Per Liter)
Change From Baseline in Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Magnesium, Blood Urea Nitrogen (BUN), and Phosphorous (Millimoles Per Liter)
+31 moreDREAMM-3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving Belantamab mafodotinExperimental Treatment1 Intervention
Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W
Group II: Participants receiving pom/dexActive Control1 Intervention
Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,147 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,108 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,605 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,079 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or have it now.I am currently experiencing bleeding from an internal site.I have symptoms of amyloidosis, POEMS syndrome, or plasma cell leukemia currently.I do not have Hepatitis B, or if I do, I meet the specific criteria for inclusion.I cannot tolerate blood clot prevention treatments.My side effects from previous treatments are mild, except for hair loss and some nerve pain.My liver condition is stable.I am at least 18 years old, or over 19 if I am from the Republic of Korea.I have had a stem cell transplant from a donor.You have specific levels of proteins in your blood and urine that can be measured.I haven't had anti-MM antibody treatment in the last 30 days.I am able to understand and sign the consent form.I have a mild eye surface condition, not severe.I've had at least 2 treatments for myeloma, including lenalidomide and a proteasome inhibitor, but my disease still progressed.I have only multiple myeloma or any other cancer I had has been stable for over 2 years.I can take care of myself and am up and about more than half of my waking hours.I am currently being treated for an infection.My blood counts, liver, and kidney functions are within normal ranges.I have had a stem cell transplant using my own cells and meet specific criteria.I haven't taken any myeloma treatment or experimental drugs recently.I tested positive for hepatitis C recently or at screening.I have multiple myeloma and have had or can't have a stem cell transplant.I have an active kidney condition.I have not had major surgery in the last 4 weeks.I have not undergone plasmapheresis within the last week.I have previously received BCMA-targeted therapy or pomalidomide.I am at risk for heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving pom/dex
- Group 2: Participants receiving Belantamab mafodotin
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
How does Belantamab mafodotin typically help patients?
"Belantamab mafodotin offers an opportunity for treatment to patients suffering from ophthalmia, sympathetic, branch retinal vein occlusion, and macular edema."
Answered by AI
In how many different healthcare facilities is this research project being undertaken today?
"Currently, there are 16 sites participating in this study; however, the locations closest to you may not be listed. The locations in Plantation, Tucson and Santa Barbara are participating in this study as well as 16 other locations. To minimize travel requirements, if you enroll, it is best to choose the location nearest you."
Answered by AI
Are we looking for new participants in this experiment?
"This specific study is no longer looking for patients, as it has already wrapped up recruitment. However, there are 826 other trials currently underway for patients with multiple myeloma and 612 studies involving Belantamab mafodotin that are actively recruiting patients."
Answered by AI
Has Belantamab mafodotin received official government sanctioning for use?
"There is both efficacy and safety data from multiple Phase 3 trials available for Belantamab mafodotin, which our team has evaluated to be a safe medication."
Answered by AI
What is the enrollment capacity for this clinical trial?
"Presently, this clinical trial is not seeking new participants. It was initially posted on April 2nd, 2020 and was last updated on September 29th, 2020. You may be interested to know that there are 826 trials actively enrolling patients with multiple myeloma and 612 studies for Belantamab mafodotin are also actively recruiting participants."
Answered by AI
Could you please tell me if there have been any other research projects conducted that are similar to Belantamab mafodotin?
"The medication known as belantamab mafodotin was first studied in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. In the years since, there have been a total of 1126 completed trials. As of right now, there are 612 live clinical trials involving this medication, with a large number of them based in Plantation, Florida."
Answered by AI
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