NP39403-RO6870810 as monotherapy and in combination in advanced MM

• Research type

  Research Study

• Full title

  Open-label, multicentre, dose-escalation/expansion Phase 1B study to evaluate safety, pharmacokinetics, and activity of BET-inhibitor RO6870810, given as mono- and combination therapy to patients with advanced multiple myeloma

• IRAS ID

  231651

• Contact name

  Rakesh Popat

• Contact email

  rakesh.popat@ucl.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2016-003615-35

• Duration of Study in the UK

  2 years, 7 months, 1 days

• Research summary

  This is a Phase 1b, open-label, multicentre, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in patients with relapsed/refractory multiple myeloma.\n\nThere are two parts to this study: dose escalation and dose expansion. \n- Dose escalation: this part of the study will establish the maximum tolerated dose and optimum biological dose of RO6870810 when given as monotherapy or combination therapy.\n- Dose expansion: this part of the study will evaluate the clinical activity of RO6870810 given as monotherapy and in combination with daratumumab.\n\nApproximately 86 patients with relapsed/refractory multiple myeloma will be enrolled in this study.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  17/SW/0247

• Date of REC Opinion

  29 Nov 2017

• REC opinion

  Further Information Favourable Opinion