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Monoclonal Antibodies
Belantamab Mafodotin for Multiple Myeloma (COSTA Trial)
Phase 2
Waitlist Available
Research Sponsored by Cristiana Costa Chase, DO
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have histologically or cytologically confirmed diagnosis of MM as defined by IMWG, 2016 criteria, have had at least 4 prior therapies, and is relapsed or refractory to an anti-CD38 antibody, an IMID, and a proteasome inhibitor
All prior treatment-related toxicities must be ≤ Grade 1 at the time of enrollment except for alopecia or at a stable baseline for at least 6 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until 70 days after the last dose of study treatment, until the subject withdraws consent for study participation, or until the subject starts subsequent anticancer therapy, whichever occurs first.
Awards & highlights
COSTA Trial Summary
This trial will explore if a drug can be safely and effectively given in a community setting every 6 weeks, rather than every 3 weeks.
Who is the study for?
Adults with a confirmed diagnosis of multiple myeloma who have tried at least four prior therapies and are resistant to certain drugs can join. They must be in good overall health, not wear contact lenses (due to eye exams required by the study), and use effective contraception. People with active infections, unstable heart or liver conditions, recent major surgery, or those on other clinical trials without approval cannot participate.Check my eligibility
What is being tested?
The trial is testing belantamab mafodotin combined with dexamethasone for relapsed/refractory multiple myeloma patients in a community setting every 6 weeks instead of the usual 3-week cycle. The aim is to see if this new schedule improves safety or affects effectiveness.See study design
What are the potential side effects?
Belantamab mafodotin may cause vision issues requiring regular eye exams and use of lubricating eye drops. Other potential side effects include skin reactions, infusion-related reactions, low blood cell counts increasing infection risk, fatigue, nausea, and fever.
COSTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple myeloma, tried at least 4 treatments, and didn't respond to specific drugs.
Select...
All my side effects from previous treatments are mild or stable for 6 weeks.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I agree to regular eye exams and to use special eye drops 4 times a day while on Belantamab mafodotin treatment.
Select...
I am 18 years old or older.
Select...
I am following the required contraceptive measures.
COSTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all adverse events whether serious or non-serious, will be reported from the start of treatment until 70 days after the last dose of study treatment, until the subject withdraws consent for study participation, or until the subject starts new treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events whether serious or non-serious, will be reported from the start of treatment until 70 days after the last dose of study treatment, until the subject withdraws consent for study participation, or until the subject starts new treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the feasibility of providing Belantamab mafodotin in a heavily pretreated, rural population of patients with multiple myeloma receiving this study regimen every 6 weeks instead of every 3-week cycles.
Secondary outcome measures
Assess the safety of belantamab mafodotin in the elderly frail population for unacceptable toxicity Grade 3 or higher
Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)
Corneal events will be graded according to the KVA Scale
+7 moreCOSTA Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment every 6 weeksExperimental Treatment1 Intervention
Treatment every 6 weeks
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?
Cristiana Costa Chase, DOLead Sponsor
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment every 6 weeks
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the biannual administration of this treatment validated by the FDA?
"This Phase 2 trial has provided some evidence of safety but not efficacy, thus resulting in a score of two for treatment every 6 weeks."
Answered by AI
Are there opportunities for volunteers to participate in this research?
"The clinical trial hosted on clinicaltrials.gov indicates that it is not currently enrolling patients. Notified of the study's existence when it was first published in June 1st 2023, and most recently updated May 16th 2023, this research project does not have any active recruitment efforts at present time; however there are 830 other studies actively searching for participants."
Answered by AI
What is the extent of the program's implementation across healthcare facilities?
"Currently, 5 sites are available for patient enrollment. The main locations include Henderson, Laurinburg and Lumberton with additional options in the area. It is suggested that prospective enrollees select a clinic nearby to reduce travel demands if they decide to join this trial."
Answered by AI
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