NCT02057640

MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma

A Phase I/II Study of MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jason Valent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the safety and tolerability of the new drug MLN9708 in combination with the existing drugs panobinostat and dexamethasone among patients with relapsed or refractory multiple myeloma. This study will also look at the response and clinical benefit of the treatment and the progression-free survival and overall survival of study participants.

Detailed description

The primary objective of this study is to define the tolerability and safety of MLN9708 (ixazomib) administered on a day 1,8,15 every 28 day schedule up to 4mg in combination with fixed doses of panobinostat and dexamethasone in patients with relapsed or refractory myeloma. The secondary objectives of this study are to assess response and clinical benefit response rates according to international uniform response criteria and adapted EBMT criteria, respectively. And to assess progression-free survival (PFS) and overall survival (OS).

Conditions

• Multiple Myeloma
• Kahler Disease
• Plasma-Cell Myeloma
• Myelomatosis

Interventions

Type	Name	Description
DRUG	Panobinostat	20mg, on day 1, 3, 5, 15, 17, 19, 28
DRUG	Dexamethasone	20mg, on day 1, 2, 8, 9, 15, 16, 28
DRUG	MLN9708	4mg on day 1, 8, 15, 28

Timeline

• Start date: 2014-05-22
• Primary completion: 2018-05-15
• Completion: 2018-05-15
• First posted: 2014-02-07
• Last updated: 2019-12-11
• Results posted: 2019-12-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study