Study Details

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A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants with Normal and Impaired Kidney Function

The purpose of this study is to learn more about how well Belantamab Mafodotin Monotherapy works for people who have relapsed or refractory multiple myeloma. We want to find out if this drug is effective for people who have normal and varying degrees of impaired kidney function.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

We will first ask some questions and do some tests (including blood, urine, imaging scans, bone marrow biopsy and aspirate) to make sure you are able to take part. If you are able to take part, you will have some questionnaires, study drug administration, and other tests and scans.

Incentives

In some situations, you may be reimbursed for the cost of travelling to your study visits. As part of the study, you will receive the study drug and all the study tests and procedures at no cost to you.

In-person visits:
At least one screening visit, one visit per cycle, one visit every three weeks, one end of treatment visit, one follow-up visit every three weeks until confirmed progressive disease, death, withdrawal of consent, or end of study. You would also be required to have an ocular exam with an eye care specialist during screening and at least once each cycle.

Total length of participation:
Treatment will continue until your study doctor decides the study drug is no longer working, you withdraw your consent, or you have severe side effects.

Looking for Specific Volunteers

Able to participate:

You have a confirmed diagnosis of multiple myeloma.
You have undergone autologous stem cell transplant or are considered transplant ineligible.
You have failed at least two prior lines of anti-myeloma therapy, including an immunomodulatory drug (e.g. lenalidomide, pomalidomide) and a proteasome inhibitor (e.g. bortezomib, carfilzomib)
You have adequate bone marrow, liver, and heart function.
You have normal or mildly impaired kidney function, severe kidney disfunction, or end stage kidney disease (not on dialysis or on hemodialisys).

Not eligible if:

You have active plasma cell leukemia at the time of screening.
You have had a prior allogeneic stem cell transplant.
You have received an investigational drug within 14 days of study drug.
You have an active infection requiring treatment.
You have had any major surgery within four weeks prior to screening.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Eben Lichtman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)

IRB Number

20-1667

ClinicalTrials.gov

NCT04398745