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Bortezomib

Dexamethasone acetate

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Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.

Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.

Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Belantamab mafodotin

Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.

Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Wojciech Janowski

Xavier Leleu

GSK Clinical Trials

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

The study will evaluate different doses/dose schedules of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone, (VRd) in up to 8 cohorts and will determine the Recommended Phase 3 dose (RP3D).

Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma

IPD for this study will be made available via the Clinical Study Data Request site.

The number of participants with DLTs will be reported.

RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

Cumulative administered dose of belantamab mafodotin in treatment in combination with VRd will be analyzed.

Blood samples will be collected at indicated time points for pharmacokinetic analysis.

Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.

ORR is defined as the percentage of participants with a confirmed partial response (PR) or better based on the response assessed by the investigator using International Myeloma Working Group (IMWG) criteria.

CRR is defined as the percentage of participants with a confirmed complete response (CR) or better based on the response assessed by the investigator using IMWG criteria.

Rate of VGPR or better is defined as the percentage of participants with a confirmed VGPR or better based on the response assessed by the investigator using IMWG criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma	NCT04091126	Multiple Myelom...	Belantamab mafo... Bortezomib Lenalidomide Dexamethasone	18 Years -	GlaxoSmithKline
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma	NCT04091126	Multiple Myelom...	Belantamab mafo... Bortezomib Lenalidomide Dexamethasone	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for rp3d

Every month we try and update this database with for rp3d cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rp3d

Every month we try and update this database with for rp3d cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rp3d cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.