This is a single-institution, single-arm, phase 2 study in which belantamab mafodotin (GSK2857916), an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), will be administered to patients with multiple myeloma prior to and following high-dose melphalan and autologous stem cell transplantation (ASCT), in conjunction with standard lenalidomide maintenance. We hypothesize that administration of belantamab mafodotin as part of autologous stem cell transplant consolidation and maintenance will be safe, well tolerated, and efficacious in comparison to historical data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
2.5 mg/kg IV
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MRD (minimal residual disease) negativity rate
Percentage of participants who have achieved minimal residual disease (MRD) negativity by next-generation sequencing (NGS) at 12 months post-autologous stem cell transplant (ASCT)
Time frame: 12 months post-ASCT
Frequency of treatment-related adverse events
Percentage of participants who develop adverse and serious adverse events, including ocular adverse events.
Time frame: through study completion, approximately 3 years
Dose reductions
The percentage of participants who require reduction of the dose of belantamab mafodotin will be assessed
Time frame: through study completion, approximately 3 years
Dose delays
The percentage of participants who require a delay in dosing of belantamab mafodotin will be assessed
Time frame: through study completion, approximately 3 years
MRD Negativity Rate
Percentage of participants who have achieved minimal residual disease (MRD) negativity by next-generation sequencing (NGS) at 3 and 24 months post-autologous stem cell transplant (ASCT)
Time frame: at 3 and 24 months post-ASCT
Overall response rate
Percentage of participants who achieve partial response (PR) or better, as assessed by International Myeloma Working Group (IMWG) criteria.
Time frame: through study completion, approximately 3 years
Very good partial response (VGPR) or better rate
Percentage of participants who achieve VGPR or better, as assessed by IMWG criteria.
Time frame: through study completion, approximately 3 years
Complete response (CR) or better rate
Percentage of participants who achieve CR or stringent CR, as assessed by IMWG criteria.
Time frame: through study completion, approximately 3 years
Progression-free survival
Time from enrollment until progression of disease by IMWG criteria, or death, whichever occurs first
Time frame: through study completion, approximately 3 years
Overall survival
Time from enrollment until death from any cause
Time frame: through study completion, approximately 3 years
Stem cell yield
The number of days required to collect sufficient autologous peripheral blood stem cells to proceed to ASCT will be assessed
Time frame: Following stem cell mobilization, about 6 weeks after enrollment
Stem cell collection days
: The number of days required to collect sufficient autologous peripheral blood stem cells to proceed to ASCT will be assessed
Time frame: Following stem cell mobilization, about 6 weeks after enrollment
Hematopoietic reconstitution post-ASCT
The number of days until neutrophil and platelet recovery post-ASCT (defined as absolute neutrophil count \>1000 cells/mcl and platelet count \>50000 cells/mcl, respectively) will be assessed
Time frame: up to 30 days post-ASCT
Change from Baseline in Health-related quality of life (HRQoL) as assessed by Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire
The FACT-MM questionnaire is a 41 item questionnaire measuring physical, social/family, emotional, and functional well-being, as well as additional concerns
Time frame: baseline through study completion, approximately 3 years.
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