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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
Must not have
Participant must not have any evidence of active mucosal or internal bleeding
Major surgery within 30 days prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any current bleeding from my internal organs or mucous membranes.
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I have not had major surgery in the last 30 days.
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I stopped taking belantamab mafodotin because of side effects.
Select...
I have had side effects from previous treatments that were mild or moderate.
Select...
My liver is currently stable, without any severe disease.
Select...
I have not had cancer other than blood cancer in the last 3 years.
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My condition is either smoldering multiple myeloma or POEMS syndrome.
Select...
I do not have any cancer other than the one being studied.
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I have symptoms of amyloidosis, POEMS syndrome, or active plasma cell leukemia.
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I do not have any current eye surface (corneal) diseases.
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I am HIV positive.
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I do not have an active kidney condition.
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I had a stem cell transplant less than a year ago or I am being treated for GvHD.
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I haven't had monoclonal antibody treatment in the last 30 days.
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I do not have hepatitis B.
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My condition did not improve after belantamab mafodotin treatment.
Select...
I do not have HIV.
Select...
I received BCMA CAR-T therapy under a special access program.
Select...
My multiple myeloma has affected my brain or spinal cord.
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 2024 Phase 1 & 2 trial • 153 Patients • NCT0354428177%
Keratopathy
69%
Thrombocytopenia
38%
Vision blurred
31%
Cough
31%
Arthralgia
31%
Diarrhoea
31%
Photophobia
31%
Fatigue
23%
Back pain
23%
Eye pain
23%
Nausea
23%
Neuropathy peripheral
23%
Bone pain
23%
Pain in extremity
23%
Epistaxis
23%
Anaemia
23%
Insomnia
15%
Neutropenia
15%
COVID-19
15%
Abdominal pain
15%
Gastrooesophageal reflux disease
15%
Vomiting
15%
Constipation
15%
Oedema peripheral
15%
Dyspnoea
15%
Pyrexia
15%
Influenza
15%
Upper respiratory tract infection
15%
Alanine aminotransferase increased
15%
Lethargy
15%
Hypophosphataemia
15%
Asthenia
15%
Hypercalcaemia
15%
Aspartate aminotransferase increased
15%
Blood creatine phosphokinase increased
8%
Irritability
8%
Conjunctival haemorrhage
8%
Joint swelling
8%
Adenoma benign
8%
Skin abrasion
8%
Influenza like illness
8%
Intraocular pressure increased
8%
Mental status changes
8%
Tachycardia
8%
Myopathy
8%
Muir-Torre syndrome
8%
Viral infection
8%
Hypoaesthesia
8%
Proteinuria
8%
Foreign body sensation in eyes
8%
Oral candidiasis
8%
Blepharitis
8%
Dry eye
8%
Hypotension
8%
Ocular hyperaemia
8%
Gastroenteritis
8%
Pneumonia
8%
Respiratory syncytial virus infection
8%
Blood creatinine increased
8%
Appetite disorder
8%
Agitation
8%
Gamma-glutamyltransferase increased
8%
Glossodynia
8%
Disease progression
8%
Visual acuity tests abnormal
8%
Decubitus ulcer
8%
Chalazion
8%
Hypocalcaemia
8%
Infusion related reaction
8%
Plasmacytoma
8%
Toxicity to various agents
8%
Weight decreased
8%
Groin pain
8%
Rash maculo-papular
8%
Neuralgia
8%
Visual acuity reduced
8%
Eye pruritus
8%
Corneal epithelium defect
8%
Meibomian gland dysfunction
8%
Dizziness
8%
Hypogammaglobulinaemia
8%
Contusion
8%
Acute kidney injury
8%
Hypokalaemia
8%
Cold sweat
8%
Rhinovirus infection
8%
Musculoskeletal chest pain
8%
Headache
8%
Peripheral sensory neuropathy
8%
Hypomagnesaemia
8%
Lentigo maligna
8%
Extrasystoles
8%
Rash
8%
Ejection fraction decreased
8%
Platelet count decreased
8%
Urine albumin/creatinine ratio increased
8%
Hyponatraemia
8%
Ageusia
8%
Fall
8%
Presyncope
8%
Clostridium difficile infection
8%
Escherichia urinary tract infection
8%
Haemorrhoids
8%
Atelectasis
8%
Bacteraemia
8%
Diabetic ketoacidosis
8%
Respiratory tract infection
8%
Blood lactate dehydrogenase increased
8%
Squamous cell carcinoma
8%
Dysgeusia
8%
Hypoxia
8%
Costochondritis
8%
Urinary tract infection
8%
Steroid diabetes
8%
Lip infection
8%
Joint dislocation
8%
Neutrophil count decreased
8%
Neck pain
8%
Anosmia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
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 2
~160
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
614 Previous Clinical Trials
1,162,834 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.
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