NCT06255847

Clinical Study of Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone in the Treatment of Patients With Debilitating RRMM

A Multicenter, Open-label Clinical Study of a Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone Regimen for the Treatment of Patients With Debilitating Relapsed-refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Shanxi Bethune Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma. Subjects meeting the enrollment criteria were screened for entry into the study and treated with the appropriate regimen; all patients enrolled in the study did not receive medications other than those specified in the regimen for the treatment of myeloma during the study period, except for supportive care. The primary endpoint of the study is ORR; secondary study endpoints include efficacy above VGPR, progression-free survival (PFS), overall survival (OS), TTNT, safety, and life scale assessment.

Conditions

• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
DRUG	Pomalidomide, cyclophosphamide combined with dexametha	The starting dose of pomalidomide was 2 mg in all cases，the starting dose of cyclophosphamide was 50 mg/day.If the adverse event is attributable to a specific study drug, the dose is reduced accordingly for that drug; if the adverse event is associated with multiple drugs, the dose is reduced appropriately for one of the predominantly associated drugs at the discretion of the investigator; and if multiple adverse events occur concurrently, the dose should be adjusted according to the guidelines for the most severe toxicity.

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2024-02-13
• Last updated: 2024-02-13

Locations

1 site across 1 country: China