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

Phase 2

Recruiting

• Conditions: Newly Diagnosed Multiple Myeloma
• Interventions: Drug: Cyclophosphamide; Drug: Lenalidomide

• Registration Number: NCT06324266
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2023-04-16
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm CTX	Cyclophosphamide	Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years
arm Len	Lenalidomide	Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years

Primary Outcome Measures

Name	Time	Method
PFS1	3 years	Progression-free Survival 1

Secondary Outcome Measures

Name	Time	Method
Incidence of Efficacy as assessed by IMWG	3 years	Efficacy assessed by IMWG
Incidence of Safety as assessed by CTCAE 4.0	3 years	Safety assessed by CTCAE 4.0

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China