A Phase Ib Study of the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Patients With Multiple Myeloma (Relapsed/Refractory and Post-Autologous Stem Cell Transplantation)
Phase of Trial: Phase I
Latest Information Update: 08 Dec 2017
At a glance
- Drugs Atezolizumab (Primary) ; Daratumumab; Lenalidomide; Pomalidomide
- Indications Multiple myeloma
- Focus Adverse reactions; Therapeutic Use
- Sponsors Genentech; Roche
- 15 Sep 2017 According to a Roche media release, based on emerging safety data from clinical trials evaluating pembrolizumab with either lenalidomide or pomalidomide in multiple myeloma, the FDA has requested that a Phase Ib (NCT02431208) and a Phase Ib/II TECENTRIQ study (NCT02631577) be placed on partial clinical hold.Patients who are currently enrolled in these trials and who are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled in these trials.
- 15 Sep 2017 Status changed from recruiting to suspended, according to a Roche media release.
- 21 Aug 2017 Planned End Date changed from 27 Aug 2019 to 26 Sep 2020.