NCT02045017

Efficacy and Safety of Pomalidomide and Dexamethasone in RRMM Patients With Renal Insufficiency

A Phase 2 Multicenter, Open-label Study to Determine the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Moderate or Severe Renal Impairment Including Subjects Undergoing Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.

Detailed description

The study will consist of a Screening phase within 28 days prior to cycle 1 day 1. Subjects once enrolled will enter the Treatment phase, in which patients will be treated until progression, or study discontinuation due to other reasons. Subjects will enter the long term Follow-up phase of the study where data will be collected every 3 months for up to 5 years on Secondary primary malignancies, survival, subsequent anti myeloma treatments and date of progression. Subjects will be recruited into one of 3 cohorts depending on the severity of their renal impairment.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Pomalidomide and Dexamethasone

Timeline

• Start date: 2014-02-28
• Primary completion: 2017-01-27
• Completion: 2021-07-28
• First posted: 2014-01-24
• Last updated: 2021-08-27

Locations

22 sites across 8 countries: Austria, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom