NCT02158702

Efficacy and Toxicity Study of Pomalidomide and Dexamethasone in Patients Who Have Relapsed After Exposure to Lenalidomide and Bortezomib

Prospective Follow-up of Relapse Myeloma Patients After Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Asian patients with relapsed myeloma after prior treatment with bortezomib and lenalidomide will treatment on pomalidomde and dexamethasone. Baseline, follow-up, survival and toxicity information will be collected.

Detailed description

Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. Recently, a randomized study of Pomalidomide and dexamethasone conducted in compared with placebo and dexamethasone showed that pomalidomide can improve survival of this group of patients. Pomalidomide is a new immunomodulatory drug which has been shown to be active in myeloma patients who relapse after bortezomib and lenalidomide. A recent phase III study comparing pomalidomide plus dexamethasone with placebo plus high dose dexamethasone in patients with prior exposure to bortezomib and lenalidomide, showed that the use of pomalidomide significantly improve the overall survival of these patients. However, this study did not include Asian patients. Therefore the efficacy and toxicity of pomalidomide remains to be described in Asian patients

Conditions

• Multiple Myeloma
• Relapse After Use of Lenalidomide and Bortezomib

Interventions

Type	Name	Description
DRUG	Pomalidomide and Dexamethasone	Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle. Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-02-01
• Completion: 2018-11-01
• First posted: 2014-06-09
• Last updated: 2018-05-17

Locations

2 sites across 1 country: Singapore