NCT06324266

Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation

Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group.

Detailed description

The investigators will conduct randomized and controlled clinical studies to preliminarily explore the efficacy and safety of low-dose cyclophosphamide in maintenance therapy for MM that is not suitable for transplantation in the standard -risk group. Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy will use cyclophosphamide or lenalidomide as maintain therapy for 2 years.

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Cyclophosphamide monotherapy for 2 years.
DRUG	Lenalidomide	Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Lenalidomide monotherapy for 2 years.

Timeline

• Start date: 2023-04-16
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: China