NCT01575925

Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)

A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.

Detailed description

The primary objective of the study is to determine the PK and safety for the combination of POM + (LD-DEX) in subjects with RRMM and impaired renal function. The secondary objective of the study is to evaluate the efficacy of POM + (LD\_DEX) in subjects with RRMM and impaired renal function. This is a 3+3 dose escalation design, with one cohort each for patients with severely impaired renal function patients (CrCl \< 30 mL/min) requiring and not requiring dialysis respectively. There will also be one control cohort with normal renal function, these patients will receive 4 mg POM. Dosing will be 21 days out of a 28 day cycle.

Conditions

• Multiple Myeloma
• Renal Impairment

Interventions

Type	Name	Description
DRUG	4 mg Oral POM + 40 mg Oral DEX
DRUG	2 mg Oral POM + 40 mg Oral DEX

Timeline

• Start date: 2012-06-01
• Primary completion: 2018-08-07
• Completion: 2018-08-07
• First posted: 2012-04-12
• Last updated: 2022-11-04

Locations

9 sites across 2 countries: United States, Canada