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

Newly Diagnosed Multiple Myeloma

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

Inclusion Criteria5

After induction and consolidation therapy (8 courses of chemotherapy), MM patients in the standard-risk group who were initially unsuitable for transplantation achieved a therapeutic effect of VGPR or above;
Secretory MM with measurable indicators;
Age ≥ 18 years old, gender unlimited;
No obvious dysfunction of heart, lungs, etc. (≤ Grade I);
General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).

Exclusion Criteria12

Cytogenetic high-risk patients;
Recurrent or refractory MM;
Using autologous hematopoietic stem cell transplantation as a consolidation therapy;
The therapeutic effect did not reach VGPR or above before enrollment;
Asymptomatic MM;
No measurable indicators;
KPS\<50%(excluding those caused by pathological fractures）；
Dysfunction of heart, lungs, etc. (\> Grade I);
Unable to cooperate in observing adverse reactions and therapeutic effects;
Pregnancy, breastfeeding, or refusal of contraception by women;
There is drug abuse and medical, psychological, or social conditions that may interfere with patients participating in research or evaluating research results;
Any unstable or potentially endangering patient safety and compliance with the study.

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.