A Phase 1/2, multicenter, open-label study to determine the recommended dose and regimen of durvalumab (MEDI4736) in combination with lenalidomide (LEN) with and without dexamethasone (dex) in subjects with newly diagnosed multiple myeloma (NDMM)
Phase of Trial: Phase I/II
Latest Information Update: 15 Dec 2017
At a glance
- Drugs Durvalumab (Primary) ; Lenalidomide (Primary) ; Dexamethasone
- Indications Multiple myeloma
- Focus Adverse reactions
- Sponsors Celgene Corporation
- 27 Sep 2017 Planned number of patients changed from 120 to 121.
- 07 Sep 2017 According to a Celgene Corporation media release, the US FDA has placed a full clinical hold on this trial, based on risks identified in other trials for an anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents.
- 07 Sep 2017 Status changed from recruiting to suspended, according to a Celgene Corporation media release.