NCT02939183

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma.

Detailed description

A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Immediate Release (IR) Formulation	Immediate Release (IR) Formulation
DRUG	Gastro-Retentive (GR) Formulation	Gastro-Retentive (GR) Formulation
DRUG	Dexamethasone	Dexamethasone
DRUG	Pomalidomide	Pomalidomide

Timeline

• Start date: 2017-01-17
• Primary completion: 2022-10-06
• Completion: 2022-10-06
• First posted: 2016-10-19
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

20 sites across 4 countries: United States, Australia, Canada, Spain