NCT02144038

Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

A Phase Ib/II, Multi-center, Study of Oral LGH447 in Combination With Oral BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients will be enrolled in the Phase II part to determine whether the combination of LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447. This trial never made it to the Phase II part of the this trial.

Conditions

• Relapsed and Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	LGH447	pan-PIM inhibitor
DRUG	BYL719	PI3K-alpha inhibitor

Timeline

• Start date: 2014-07-23
• Primary completion: 2015-10-28
• Completion: 2015-10-28
• First posted: 2014-05-21
• Last updated: 2020-12-17

Locations

8 sites across 5 countries: United States, Australia, Germany, Italy, Singapore