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Monoclonal Antibodies
Combination Therapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Ashraf Badros, MB; ChB
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior treatment-related toxicities must be ≤ Grade 1 except peripheral neuropathy (Grade-2)
Histologically confirmed diagnosis of Refractory MM; failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody and is refractory to an IMiD and to a proteasome inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death from any cause, assessed up to 100 months
Awards & highlights
Study Summary
This trial is testing a new combination drug treatment for multiple myeloma, a cancer of the blood.
Who is the study for?
This trial is for adults with Multiple Myeloma that's come back or hasn't responded to treatment. They must have tried at least three prior treatments, including specific anti-myeloma drugs, and not had certain stem cell transplants recently. Participants need good organ function, no active infections, and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of combining Belantamab Mafodotin with Cyclophosphamide and Dexamethasone in patients whose Multiple Myeloma has relapsed or is refractory. It aims to see how well this combination works as a treatment option.See study design
What are the potential side effects?
Potential side effects include eye problems like blurry vision, blood disorders such as low platelet counts, infusion reactions from the drug entering the body, fatigue, nausea, fever, respiratory infections and potential liver issues.
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 possible moderate nerve pain.
Select...
I have multiple myeloma and previous treatments, including specific antibodies and inhibitors, didn't work.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of the day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of death from any cause, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death from any cause, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall incidence and severity of AEs in Dose Escalation
Response rate in Expansion Cohort
Secondary outcome measures
Cytokine Profile Data
Overall survival
Progression free survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Group II: Arm AExperimental Treatment1 Intervention
Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,636 Total Patients Enrolled
10 Trials studying Multiple Myeloma
114 Patients Enrolled for Multiple Myeloma
Ashraf Badros, MB; ChBPrincipal InvestigatorUniversity of Maryland, Baltimore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I have been cancer-free from any other cancer for more than 2 years.I have tested positive for hepatitis B recently.I am allergic to belantamab mafodotin, daratumumab, bortezomib, boron, mannitol, or similar drugs.My liver condition is currently unstable.You have a certain amount of abnormal proteins in your blood or urine.I have had a stem cell transplant from a donor.I am using birth control as required by local laws for clinical study participants.I had a stem cell transplant or BCMA therapy over 100 days ago, with no current infections and my organs work well.I have a heart condition.I have symptoms of amyloidosis, POEMS syndrome, or plasma cell leukemia currently.I have a mild eye surface condition, not severe.I do not have active brain disease, blood cancer, or amyloidosis symptoms.I am currently being treated for an infection.My side effects from previous treatments are mild, except for possible moderate nerve pain.I am currently experiencing active bleeding.I have multiple myeloma and previous treatments, including specific antibodies and inhibitors, didn't work.I haven't had myeloma treatment or plasmapheresis in the last 2 weeks.I have not had any major surgery in the last four weeks.I haven't taken high dose steroids in the last 14 days.I am not taking strong medications that affect drug transport in my body.You have tested positive for hepatitis C within the last 3 months before starting the study.I am 18 years old or older.I have kidney issues, but my protein levels are okay.I can take care of myself and am up and about more than half of the day.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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 is the maximum number of participants allowed in this research endeavor?
"Affirmative, based on the information published on clinicaltrials.gov, this research trial is currently recruiting participants. This study was initially posted in early January and recently updated at the end of month. The team intends to enroll 64 individuals from a single location."
Answered by AI
What is the primary aim of this clinical research?
"This medical trial's primary outcome, which is to be monitored for up to 12 weeks, entails evaluating the overall incidence and intensity of adverse events in a dose escalation experiment. Secondary objectives comprise measuring the time until progression of symptoms, analyzing cytokine profile data (such as IL-4, CXCL10 (IP-10), etc.), and assessing Progression Free Survival - or how long it takes for study drugs to control disease development."
Answered by AI
Are there any slots available for prospective participants in this clinical trial?
"According to information stored on clinicaltrials.gov, this trial is actively searching for participants with the initial post-date set at January 1st 2022 and latest edit logged as of January 24th 2022."
Answered by AI
What medical condition is Belantamab Mafodotin, Cyclophosphamide and Dexamethasone commonly prescribed for?
"Belantamab Mafodotin, Cyclophosphamide and Dexamethasone are frequently prescribed to treat synovitis. This potent mix can also be used for ophthalmia, sympathetic pathologies, lung cancers, as well as branch retinal vein occlusion."
Answered by AI
To what extent has Belantamab Mafodotin, Cyclophosphamide and Dexamethasone been tested as part of other clinical trials?
"Presently, 1293 trials are evaluating Belantamab Mafodotin, Cyclophosphamide and Dexamethasone. Of these studies, 268 are in their concluding phase 3. Despite the majority of research being conducted around Philadelphia Pennsylvania, a total 41370 locations have active clinical trials for this drug combination."
Answered by AI
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