NCT02555839

Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice

Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously treated with Lenalidomide and Bortezomib, due to poor prognosis. This observational study focuses on the collection of data concerning the safe and optimal usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage and efficacy will be performed. This knowledge could lead to a optimization of Pomalidomide usage and treatment.

Detailed description

There is a high unmet medical need for further anti-myeloma therapy in patients with RRMM who have previously been treated with Lenalidomide and Bortezomib containing regimens that is both active and tolerable, as these patients have a poor prognosis. Hands-on experience with Pomalidomide is very limited in Austria and a non-interventional study enhances the attention paid to safe use and handling of the product as well as increase knowledge about optimal adverse event (AE) management substantially. A detailed record of the medical history including. co-morbidities and pre-treatment regimens will allow analysis of the impact there of on tolerability, dosage and efficacy. Beside the collection of data on efficacy and tolerability this observational drug utilization study could give insight into the clinical practice and the routine use of Pomalidomide.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Pomalidomide	4mg capsule on d1 through 21 of a 28 day cycle
DRUG	Dexamethasone	40 mg (≤75 years) or 20mg (\>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
DRUG	Pomalidomide	4mg capsule on d1 through 14 of a 21 day cycle
DRUG	Dexamethasone	cycle 1-8: 20mg PO (≤75 years) or 10mg (\>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle; from cycle 9 onwards: Dexamethasone 20mg PO (≤75 years) or 10mg (\>75years) on Days 1, 2, 8, 9 of a 21 day cycle
DRUG	Bortezomib	cycle 1-8: Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle; from cycle 9 onwards: Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle,

Timeline

• Start date: 2015-02-20
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2015-09-22
• Last updated: 2025-03-28

Locations

13 sites across 1 country: Austria