DREAMM 6 : A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma

Trial Identifiers

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• NCT03544281

Scientific Title

A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma

Commercial Sponsor

GlaxoSmithKline

Summary

This is a 2-Part, non-randomised trial. Part 1 is dose escalation phase and Part 2 is dose expansion phase. In each part of the trial, patients will receive 2 treatments, A and B. In Part 1, patients will receive GSK2857916, at dose of 2.5 mg/kg with either Len/Dex or Bor/Dex (Arm A and B), if well tolerated escalated to 3.4 mg/kg in next cohort of patients to determine the recommended phase two (RP2D) dose. If not tolerated, lower dose, 1.9 mg/kg, will be administered. In Part 2 (Dose Expansion Phase) additional patients will be treated at the RP2D of GSK2857916 with either Len/Dex or Bor/Dex (Arm A and B) to assess the clinical activity of those combinations.