NCT05509374

Phase II Study of Carfilzomib, Pomalidomide, and Dexamethasone for Myeloma Patients Who Had Relapsed or Progressed After Carfilzomib, Lenalidomide, and Dexamethasone

Phase II, Single-arm Trial of Carfilzomib, Pomalidomide, and Dexamethasone for Myeloma Patients Who Had Relapsed or Progressed After Carfilzomib, Lenalidomide, and Dexamethasone

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the evaluate the efficacy and safety of administering a combination of carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or advanced multiple myeloma after carfilzomib, lenalidomide, and dexamethasone therapy.

Detailed description

This study is a phase 2 study in which patients with RRMM under 80 years of age who have been treated with lenalidomide monotherapy for at least 6 months after KRd combination therapy will receive carfilzomib, pomalidomide, and dexamethasone combination therapy. A total of 33 participants are recruited. KPd will be administered until progressive disease or unacceptable toxicities. Participants who discontinued treatment will be followed up for disease status and survival at 2-month intervals. Responses are assessed using the International Myeloma Working Group (IMWG) response criteria and the safety profile is described using NCI-CTCAE v5.0.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib 56 MG [Kyprolis]	Carfilzomib 56 mg/m2 (Day1, 8, 15) (Cycle1 Day1, 20 mg/m2)
DRUG	Pomalidomide	Pomalidomide 4 mg per os (Day1-21)
DRUG	Dexamethasone	Dexamethasone 40 mg (D1, 8, 15, 22) (20 mg for patients ≥ 75 years old)

Timeline

• Start date: 2021-10-28
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-08-22
• Last updated: 2022-08-22

Locations

1 site across 1 country: South Korea