Clinical trial NCT06324266: Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation
Official title: Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Newly Diagnosed Multiple Myeloma
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS1
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of Efficacy as assessed by IMWG
timeFrame: 3 years
measure: Incidence of Safety as assessed by CTCAE 4.0
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Department of Hematology of Jinling Hospital
name: Li Feng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: