Your session is about to expire
← Back to Search
Monoclonal Antibodies
Belantamab Mafodotin for Multiple Myeloma (DREAMM 14 Trial)
Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
Histologically or cytologically confirmed diagnosis of MM and has undergone stem cell transplant or is considered transplant ineligible, and has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody alone or in combination and is refractory to an immunomodulatory agent and a proteasome inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
DREAMM 14 Trial Summary
This trial will test different ways of giving the drug belantamab mafodotin to people with a certain kind of blood cancer to see if it can be more effective with fewer side effects.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including specific antibody and inhibitor therapies. They must be in relatively good health (ECOG 0-2), not pregnant, willing to use contraception, and without serious liver, kidney, bleeding disorders or other severe conditions that could affect safety.Check my eligibility
What is being tested?
The study tests different doses and schedules of belantamab mafodotin to find a better balance between benefits and risks for patients with multiple myeloma. It's only for those whose disease has returned after treatment or didn't respond to previous therapies.See study design
What are the potential side effects?
Belantamab mafodotin can cause eye problems like blurry vision, dry eyes; blood cell count changes leading to increased infection risk; fatigue; infusion reactions during drug administration; and potential liver issues.
DREAMM 14 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older and can sign the consent form.
Select...
I have MM, failed 3 treatments including CD38 antibody, and can't have or failed a stem cell transplant.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have tried at least 4 different treatments for myeloma without success.
DREAMM 14 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence rate of Grade ≥2 Corneal events according to the keratopathy visual acuity (KVA) scale
Secondary outcome measures
Area under the concentration time-curve (AUC) of belantamab mafodotin
Change in best corrected visual acuity (BCVA)
Cumulative event rate of corneal events to Week 16 (KVA scale)
+22 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
DREAMM 14 Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modificationExperimental Treatment1 Intervention
Group II: Cohort 4: Participants receiving belantamab mafodotin at DL 4Experimental Treatment1 Intervention
Group III: Cohort 3: Participants receiving belantamab mafodotin at DL 3Experimental Treatment1 Intervention
Group IV: Cohort 2: Participants receiving belantamab mafodotin at DL 2Experimental Treatment1 Intervention
Group V: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1Experimental Treatment1 Intervention
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
4,758 Previous Clinical Trials
8,103,966 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,253 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,776 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,224 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count is very low, or your platelet count is very low.You have a detectable disease according to specific criteria.I am 18 years old or older and can sign the consent form.I do not have cirrhosis or current unstable liver or biliary disease.I am currently on medication for an infection.I do not have any eye surface diseases, except for minor SPK.I can take care of myself and am up and about more than half of my waking hours.Your alanine aminotransferase (ALT) level is more than 2.5 times the upper limit of normal.I have been cancer-free from other types of cancer for more than 2 years, except for non-melanoma skin cancer.I haven't taken high dose steroids in the last 14 days.I have not had major surgery within the last 4 weeks, except for bone surgery.You show signs of heart problems based on the study's rules.I haven't had monoclonal antibody treatment in the last 30 days, except for conditions like COVID.I have MM, failed 3 treatments including CD38 antibody, and can't have or failed a stem cell transplant.I have not been treated with BCMA-targeted therapy or had allergic reactions to similar treatments.I have a current kidney condition.I agree to follow the study's birth control rules.My blood counts and kidney function are not within the required range for the trial.I have tried at least 4 different treatments for myeloma without success.I am able to understand and sign the consent form.I have symptoms of amyloidosis, POEMS syndrome, or active plasma cell leukemia.You have hepatitis B or C, unless you meet certain requirements in the study's guidelines.I am receiving treatment with a drug that combines an antibody with chemotherapy.I am currently experiencing bleeding from an internal organ or mucosa.I have had a stem cell transplant from a donor.I haven't taken any systemic anti-MM therapy in the last 14 days or less than 5 half-lives.Your bilirubin levels are higher than 1.5 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4: Participants receiving belantamab mafodotin at DL 4
- Group 2: Cohort 2: Participants receiving belantamab mafodotin at DL 2
- Group 3: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
- Group 4: Cohort 3: Participants receiving belantamab mafodotin at DL 3
- Group 5: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
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.
What indications is Belantamab mafodotin most often applied to?
"Belantamab mafodotin can be used to immunomodulate, as well as treat patients that have relapsed or refractory multiple myeloma and have previously received proteasome inhibitor treatment."
Answered by AI
Is Belantamab mafodotin a safe medication for human consumption?
"Belantamab mafodotin is currently in Phase 2 of clinical trials, meaning that while there is some evidence supporting its safety, none yet supports its efficacy."
Answered by AI
How many volunteers are testing this new treatment?
"That is correct. The online database clinicaltrials.gov has the most recent information on this study, which was updated on 11/2/2022. This particular trial is looking for 180 patients and has 10 sites across the nation that are admitting participants."
Answered by AI
At how many different sites is this research being conducted?
"Presently, this study is enrolling patients at 10 different locations which include Toronto, Oshawa and New Port Richey. If you are considering enrolling in this trial, it may be best to choose a location near to reduce travel time and effort."
Answered by AI
Are people currently signing up for this experiment?
"The study is still looking for volunteers, as of the latest update on clinicaltrials.gov which was on November 2nd, 2022. The original posting date for this trial was March 3rd, 2020."
Answered by AI
How does the effectiveness of Belantamab mafodotin compare to other treatments?
"The first study involving belantamab mafodotin was conducted in 2015 by Weill Cornell Medicine / NewYork Presbyterian Hospital. As of right now, 33 different trials are ongoing with a large portion of them taking place in Toronto, Ontario."
Answered by AI
Has this research been conducted before?
"Belantamab mafodotin is being studied in 33 ongoing trials across 221 cities and 34 countries. The very first study was sponsored by Karyopharm Therapeutics Inc. in 2015 and it completed Phase 1 & 2 drug approval that same year with the help of 518 patients. Since then, two more trials have concluded."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger