This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment. The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Belantamab mafodotin will be administered.
Dexamethasone will be administered.
Pomalidomide will be administered.
Bortezomib will be administered.
Carfilzomib will be administered.
GSK Investigational Site
Los Alamitos, California, United States
RECRUITINGGSK Investigational Site
Torrance, California, United States
RECRUITINGGSK Investigational Site
Whittier, California, United States
RECRUITINGGSK Investigational Site
Fort Myers, Florida, United States
RECRUITINGGSK Investigational Site
Macon, Georgia, United States
RECRUITINGGSK Investigational Site
Bethesda, Maryland, United States
RECRUITINGGSK Investigational Site
Bridgeton, Missouri, United States
RECRUITINGGSK Investigational Site
Springfield, Missouri, United States
RECRUITINGGSK Investigational Site
Farmington, New Mexico, United States
RECRUITINGGSK Investigational Site
Paris, France
RECRUITING...and 17 more locations
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed partial response \[PR\] or better (i.e., PR, very good partial response (VGPR), complete response \[CR\], stringent complete response \[sCR\]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.
Time frame: Up to approximately 52 months
Complete Response Rate (CRR)
CRR is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR).
Time frame: Up to approximately 52 months
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status (as assessed by Next generation sequencing \[NGS\] at 10\^-5 threshold) at least once during the time of confirmed CR or better response as per IMWG.
Time frame: Up to approximately 52 months
Duration of Response (DoR)
DoR is defined as the time from first documented evidence of PR or better until PD or death due to any cause.
Time frame: Up to approximately 52 months
Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity
Time frame: Up to approximately 52 months
Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation
Time frame: Up to approximately 52 months
Number of Participants With Ocular Findings on Ophthalmic Examination by severity
Time frame: Up to approximately 52 months
Proportion of participants showing concordance between patient-reported ocular symptoms and ophthalmic examination findings
Ophthalmic examination findings will be summarized, and contingency table will be constructed to assess the concordance between the results from patient questionnaires (Ocular Surface Disease Index \[OSDI\], PRO-CTCAE ocular scale, and PROSIM-Q) and findings from clinician assessments (CTCAE for eye disorders and Keratopathy and Visual Acuity \[KVA\] grading scale). The proportion of participants showing concordance will be calculated from this analysis.
Time frame: Up to approximately 52 months
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