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Monoclonal Antibodies
Belantamab Mafodotin for Multiple Myeloma (EMBRACE Trial)
Phase 2
Recruiting
Led By Saurabh Chhabra, MD, MS
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of multiple myeloma with measurable disease prior to receiving CAR-T
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
EMBRACE Trial Summary
This trial is testing a new drug, belantamab mafodotin, as a possible treatment for multiple myeloma that has returned or does not respond to other treatments. The drug will be given as an IV on day 1 of each cycle, and the trial will last for 56 days.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had at least three prior treatments and stable disease post-CAR-T therapy. They must have good organ function, not be pregnant or breastfeeding, use contraception, and have no history of severe reactions to belantamab mafodotin or similar drugs.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a drug called Belantamab Mafodotin as maintenance therapy after CAR-T cell treatment in patients with multiple myeloma. Participants will receive this drug every two months following their initial CAR-T therapy.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision, dry eyes; blood disorders; infusion-related reactions; fatigue; nausea; fever; respiratory infections. The severity can vary from mild to serious.
EMBRACE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple myeloma that can be measured and am about to receive CAR-T therapy.
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I am 18 years old or older.
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I've had 3 treatments before CAR-T and haven't worsened after CAR-T.
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My blood tests show enough hemoglobin, platelets, and neutrophils.
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I agree not to donate sperm and to use birth control or abstain from sex.
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My condition hasn't worsened after receiving CAR-T therapy.
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My liver tests are within the normal range.
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I am a male and will use the required contraception methods.
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I have taken a pregnancy test recently and it was negative.
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I am able to care for myself and perform daily activities.
EMBRACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of patients with 12-month progression-free survival.
Secondary outcome measures
Overall survival for the entire study population from the time of CAR-T administration.
Side 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%
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
17%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin
EMBRACE Trial Design
1Treatment groups
Experimental Treatment
Group I: belantamab mafodotinExperimental Treatment1 Intervention
Belantamab mafodotin is an intravenous drug.
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?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,538 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,681 Patients Enrolled for Multiple Myeloma
Saurabh Chhabra, MD, MSPrincipal InvestigatorMedical College of Wisconsin
Meera Mohan, MD, MSPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any current bleeding from my internal organs or mucous membranes.I have not had major surgery in the last 30 days.I have not had major surgery in the last four weeks.I stopped taking belantamab mafodotin because of side effects.I have not had an infection needing treatment in the last 2 weeks.I have had side effects from previous treatments that were mild or moderate.My liver is currently stable, without any severe disease.I have multiple myeloma that can be measured and am about to receive CAR-T therapy.I am 18 years old or older.You are expected to live for at least six more months.I've had 3 treatments before CAR-T and haven't worsened after CAR-T.I am using birth control as required by my local laws.I have not had cancer other than blood cancer in the last 3 years.My condition is either smoldering multiple myeloma or POEMS syndrome.You cannot have had a bad reaction to belantamab mafodotin or similar drugs in the past.I am at risk for heart disease.I do not have any cancer other than the one being studied.You have a medical condition that might make it hard for you to follow the study's rules or understand what you are agreeing to.Your kidneys are working well enough to clear waste from your body.I have symptoms of amyloidosis, POEMS syndrome, or active plasma cell leukemia.My blood tests show enough hemoglobin, platelets, and neutrophils.The amount of protein in your urine is less than 500 mg per gram of creatinine, or your urine test shows no to very little protein.I do not have any current eye surface (corneal) diseases.I had a transplant from another person over a year ago and may be treating skin GVHD.I agree not to donate sperm and to use birth control or abstain from sex.I haven't taken any experimental drugs or standard myeloma treatments in the last 14 days.My condition hasn't worsened after receiving CAR-T therapy.I do not have any serious health or mental conditions that could affect my safety in the trial.I am HIV positive.I do not have hepatitis C.I had a stem cell transplant less than a year ago or I am being treated for GvHD.I haven't had any live vaccines in the last 30 days.I do not have an active kidney condition.I haven't had monoclonal antibody treatment in the last 30 days.My liver tests are within the normal range.I do not have hepatitis B.I have not undergone plasmapheresis in the last week.I am a male and will use the required contraception methods.I have taken a pregnancy test recently and it was negative.I am able to care for myself and perform daily activities.My condition did not improve after belantamab mafodotin treatment.I do not have HIV.I received BCMA CAR-T therapy under a special access program.My multiple myeloma has affected my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: belantamab mafodotin
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.
To what extent has this clinical trial been populated with participants?
"Affirmative. Clinicaltrials.gov displays information that this trial, which was first made available on July 19th 2022, is still recruiting patients to participate. 45 individuals are being sought from a single centre of inquiry."
Answered by AI
Have there been any prior reports on Belantamab mafodotin's efficacy?
"Currently, 33 clinical trials are being conducted to explore the efficacy of Belantamab mafodotin. Of those studies 4 have reached phase 3 and many of these experiments originate from Poitiers cedex, Baden-Wuerttemberg; however 875 different sites around the world are participating in its investigation."
Answered by AI
Is this trial currently open to participants?
"According to the data published on clinicaltrials.gov, this experiment is currently open for recruitment and was last modified on August 3rd 2022. The trial initially went live July 19th of the same year."
Answered by AI
Is Belantamab mafodotin a secure treatment for patients?
"This Phase 2 trial has yielded some evidence of Belantamab mafodotin's safety, rendering the compound a score of two on our team at Power's scale. However, there is yet to be data confirming its efficacy."
Answered by AI
Does this clinical trial represent an unprecedented approach to treatment?
"Currently, there are 33 active trials for Belantamab mafodotin in 221 cities and 34 nations. This drug first entered into clinical studies back in 2015 when Karyopharm Therapeutics Inc sponsored a Phase 1 & 2 trial with 518 volunteers. Since then, two more studies have been conducted."
Answered by AI
What is the primary application of Belantamab mafodotin?
"Belantamab mafodotin has a range of therapeutic applications, including immunomodulation and the management of relapsed or refractory multiple myeloma in addition to other conditions linked to previous proteasome inhibitor treatment and anti-cd38 monoclonal antibody therapy."
Answered by AI
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