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Trial Summary


Protocol No.207497
StatusOPEN TO ACCRUAL
Principal InvestigatorAbonour, Rafat
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA 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 DREAMM-6
DescriptionThis is a 2-part study, where Part 1 will be dose-escalation phase and Part 2 will be dose expansion phase. Part 1 will first evaluate the safety and tolerability profile of 2 doses of GSK2857916, when administered in combination with approved regimens of either lenalidomide plus dexamethasone (Arm A) or bortezomib plus dexamethasone (Arm B) and will identify a recommended Phase 2 dose (RP2D) for each combination treatment (Part 1). Part 2 of the study will evaluate the clinical activity at the RP2D for GSK2857916 in combination with lenalidomide plus dexamethasone (Arm A) or bortezomib plus dexamethasone (Arm B) in additional subjects with RRMM. A total of 90 evaluable subjects will be enrolled in the study of which up to 24 will be included in Part 1 and up to 66 will be included in Part 2. Subjects receiving treatment A, may continue combination treatment until the occurrence of PD, intolerable (AEs), consent withdrawal, or death. The subjects receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the subjects will continue treatment with GSK2857916, as monotherapy until PD, intolerable AEs, consent withdrawal, or death.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • 18 Years and older
  • Diagnosis of Multiple Myeloma
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesMultiple Myeloma
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu