NCT03242460

The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM)

The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Who Had Lenalidomide Plus Dexamethasone (LD) Following Frontline Bortezomib Combined Chemotherapy, Open-labeled, Multicenter Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Kosin University Gospel Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse the second-line LD when the bortezomib-containing treatment failed to salvage the patients. Patients who have relapsed MM after exposure to the above agents and have progressive disease have a short life expectancy. Third-line therapy is needed for retrieving the patients hereafter. And substantial proportion of patients will attain an advanced age. To examine if time to disease progression is maintained and tolerability is improved with lower dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is achieved after 3 months of treatment with the initial dose. Three months later (6 months after the initial treatment), the response remains in stable disease, 2nd dose reduction (dexamethasone 10mg or prednisone 50mg) will be carried out.

Conditions

• Relapsed and/or refractorY Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Pomalidomide 4 MG	Pomalidomide 4mg Days 1-21
DRUG	Dexamethasone 20mg	Dexamethasone 20mg Days 1, 8, 15, 22
DRUG	Cyclophosphamide 400mg	Cyclophosphamide 400mg Days 1, 8, 15

Timeline

• Start date: 2015-05-12
• Primary completion: 2019-04-24
• Completion: 2019-05-02
• First posted: 2017-08-08
• Last updated: 2020-02-20

Locations

1 site across 1 country: South Korea