Study of Daratumumab in Combination With Dexamethasone in Resistant or Refractory Multiple Myeloma

Summary

This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease, resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide. There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling have already been determined in previous phase 1-2 dose escalation studies. There is no randomization.

Timeline

Start

2015-12-28

Primary completion

2020-03-09

Completion

2020-03-09

Publications

• Results Boyle EM, Leleu X, Petillon MO, Karlin L, Doyen C, Demarquette H, Royer B, Macro M, Moreau P, Fostier K, Marie-Lorraine C, Zarnitsky C, Perrot A, Herbaux C, Poulain S, Manier S, Beauvais D, Walker BA, Wardell CP, Vincent L, Frenzel L, Caillon H, Susanna S, Dejoie T, Avet-Loiseau H, Mohty M, Facon T; IFM2014-04 investigators. Daratumumab and dexamethasone is safe and effective for triple refractory myeloma patients: final results of the IFM 2014-04 (Etoile du Nord) trial. Br J Haematol. 2019 Nov;187(3):319-327. doi: 10.1111/bjh.16059. Epub 2019 Jun 19.

Drugs

Indications