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

Jinling Hospital, China

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Newly Diagnosed Multiple Myeloma

Treatments: Drug: Cyclophosphamide; Drug: Lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT06324266

2023NZKY-044-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Secretory MM with measurable indicators;
3. Age ≥ 18 years old, gender unlimited;
4. No obvious dysfunction of heart, lungs, etc. (≤ Grade I);
5. General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

arm CTX

Experimental group

Description:

Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years

Treatment:

Drug: Cyclophosphamide

arm Len

Placebo Comparator group

Description:

Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years

Treatment:

Drug: Lenalidomide