GSK 207497 dreaMM-6

• Research type

  Research Study

• Full 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 - (dreaMM 6)

• IRAS ID

  247361

• Contact name

  Adam Forbes

• Contact email

  adamforbes@nhs.net

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2017-004689-93

• Duration of Study in the UK

  3 years, 9 months, 25 days

• Research summary

  The purpose of this study is to evaluate the safety of the study drug, GSK2857916, at different doses and how well it works to treat patients with multiple myeloma when taken together with Lenalidomide Plus Dexamethasone (Treatment Arm A), or Bortezomib Plus Dexamethasone (Treatment Arm B).\n\nGSK2857916 is not yet approved by regulatory authorities for doctors to treat patients with relapsed or refractory multiple myeloma (RRMM). Lenalidomide Plus Dexamethasone (Len/Dex) or Bortezomib Plus Dexamethasone (Bor/Dex) are approved drugs and are used as Standard of Care (SoC) to treat patients with multiple myeloma. However, Len/dex or Bor/Dex are not yet approved to be used in combination with GSK2857916 in multiple myeloma. It is therefore being studied to see how well GSK2857916 works in combination with Len/Dex or Bor/Dex in multiple myeloma. \n\nPart 1, the recommended Phase 2 dose (RP2D) of GSK2857916 will be identified for the combination of Treatment A or Treatment B while assessing the safety and tolerability profile. While Part 2 will look into the clinical activity of the RP2D for GSK2857916 in combination with Treatment A or Treatment B. \n\nAbout 90 patients (24 in Part 1 & 66 in Part 2) in approximately 6 different countries will take part in this study\n\n

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  18/SW/0225

• Date of REC Opinion

  12 Dec 2018

• REC opinion

  Further Information Favourable Opinion