The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, pomalidomide, and dexamethasone and to establish the recommended Phase 2 dose for combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Belantamab mafodotin will be administered.
Nirogacestat will be administered.
Pomalidomide will be administered.
GSK Investigational Site
Salvador, Estado de Bahia, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Dose Exploration (DE) Phase: Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to 21 days
DE Phase: Number of participants with adverse events (AEs)
Time frame: Up to approximately 137 weeks
DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry, and urinalysis lab parameters
Time frame: Up to approximately 137 weeks
Cohort Expansion (CE) Phase: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Partial response (PR) or better as the best overall response (BOR), according to the International Myeloma Working Group (IMWG) Response Criteria.
Time frame: Up to approximately 137 weeks
DE Phase: Overall Response Rate
ORR is defined as the percentage of participants with confirmed PR or better as BOR, according to the IMWG Response Criteria.
Time frame: Up to approximately 236 weeks
CE Phase: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a confirmed minimal response (MR) or better as BOR, according to IMWG response criteria.
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants achieving Partial Response (PR)
Number of participants with PR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants achieving PR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dexamethasone will be administered.
Villejuif, France
GSK Investigational Site
Mexico City, Mexico
GSK Investigational Site
Oslo, Norway
GSK Investigational Site
Lublin, Poland
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Ulsan, South Korea
GSK Investigational Site
Falun, Sweden
Number of participants with PR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants achieving Very Good Partial Response (VGPR)
Number of participants with VGPR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants achieving VGPR
Number of participants with VGPR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants achieving Complete Response (CR)
Participants with CR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants achieving CR
Participants with CR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants achieving Stringent Complete Response (sCR)
Participants with sCR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants achieving sCR
Participants with sCR according to IMWG criteria will be analysed.
Time frame: Up to approximately 236 weeks
DE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments
Time frame: Up to approximately 236 weeks
CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments
Time frame: Up to approximately 236 weeks
DE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin
Time frame: Up to approximately 236 weeks
CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin
Time frame: Up to approximately 236 weeks
DE Phase: Pomalidomide concentration when administered in combination with belantamab mafodotin
Time frame: Up to approximately 236 weeks
CE Phase: Pomalidomide concentration when administered in combination with belantamab mafodotin
Time frame: Up to approximately 236 weeks
DE Phase: Dexamethasone concentration when administered in combination with belantamab mafodotin
Time frame: Up to approximately 236 weeks
CE Phase: Dexamethsone concentration when administered in combination with belantamab mafodotin
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin
Time frame: Up to approximately 236 weeks
DE Phase: Titre of (ADAs) against belantamab mafodotin
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with ADAs against belantamab mafodotin
Time frame: Up to approximately 236 weeks
CE Phase: Titre of ADAs against belantamab mafodotin
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants with adverse events of special interest (AESI) for belantamab mafodotin
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AESI for belantamab mafodotin
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants with AESI for Nirogacestat
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AESI for Nirogacestat
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants with AESI for Pomalidomide
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AESI for Pomalidomide
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants with AESI for Dexamethasone
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AESI for Dexamethasone
Time frame: Up to approximately 236 weeks
DE Phase: Number of participants with abnormal ocular findings on ophthalmic examination
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination
Time frame: Up to approximately 236 weeks
CE Phase: Progression-free survival (PFS)
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
Time frame: Up to approximately 236 weeks
CE Phase: Duration of response (DoR)
DoR is defined as the time from first documented evidence of confirmed PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
Time frame: Up to approximately 236 weeks
CE Phase: Time to response (TTR)
TTR is defined as the time between the date of randomization and the first documented evidence of response (confirmed PR or better), among participants who achieve a response (confirmed PR or better).
Time frame: Up to approximately 236 weeks
CE Phase: Overall survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AEs and SAEs
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with AE leading to dose reduction or delay
Time frame: Up to approximately 236 weeks
CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
Time frame: Up to approximately 236 weeks