Last updated on August 2019

To Evaluate Safety Tolerability and Clinical Activity of the Antibody-drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A) or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Brief description of study

This study will evaluate the safety and tolerability profile of GSK2857916 when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study is a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of GSK2857916 in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of GSK2857916 at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex.

Up to a total of 123 evaluable participants will be enrolled in the study with up to 33 Part 1 and up to 90 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, or death. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with GSK2857916, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, or death.

Clinical Study Identifier: NCT03544281

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GSK Investigational Site

Melbourne, Australia
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Fitzroy, Australia
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