RecruitingPhase 2Phase 3NCT06324266

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


Sponsor

Jinling Hospital, China

Enrollment

80 participants

Start Date

Apr 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low dose of cyclophosphamide (a chemotherapy drug, abbreviated CTX) can work as ongoing maintenance therapy for people with multiple myeloma (a blood cancer affecting plasma cells) who are not candidates for stem cell transplant and who achieved a very good response to initial treatment. **You may be eligible if:** - You have multiple myeloma that is secretory (produces measurable proteins in the blood or urine) - You are 18 years or older - You completed induction and consolidation therapy (8 courses of chemotherapy) and achieved at least a very good partial response (VGPR) - You were not suitable for stem cell transplant - Your heart and lung function are adequate (grade I or below) - Your overall performance score (KPS) is at least 70% **You may NOT be eligible if:** - You have high cytogenetic risk features (specific chromosome changes that make the cancer more aggressive) - Your myeloma has relapsed or become refractory - You underwent autologous stem cell transplant as consolidation - You did not achieve at least a VGPR response before enrollment - Your cancer is asymptomatic (smoldering myeloma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

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.

DRUGLenalidomide

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.


Locations(1)

Jinling Hospital

Nanjing, Jiangsu, China

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NCT06324266


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