Pembrolizumab (MK-3475) in MM Patients With Residual Disease

Summary

This is a national, multicenter, open label single-arm, non-comparative study that will determine the efficacy, safety and the changes in selected pharmacodynamics markers of MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a response with a previous treatment but who still display some residual disease. For this purpose, 20 MM patients, who have received any treatment of limited duration either at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks for 1 year, with a potential expansion of 1 additional year of treatment in case of clinical benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be evaluated to understand the role of this monoclonal antibody in this setting.

Timeline

Start

2016-06

Primary completion

2017-07

Completion

2020-02-20

Publications

• Puig N, Corchete-Sanchez LA, Perez-Moran JJ, Davila J, Paino T, de la Rubia J, Oriol A, Martin-Sanchez J, de Arriba F, Blade J, Blanchard MJ, Gonzalez-Calle V, Garcia-Sanz R, Paiva B, Lahuerta JJ, San-Miguel JF, Mateos MV, Ocio EM. Pembrolizumab as Consolidation Strategy in Patients with Multiple Myeloma: Results of the GEM-Pembresid Clinical Trial. Cancers (Basel). 2020 Dec 3;12(12):3615. doi: 10.3390/cancers12123615.

Drugs

Indications