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

Newly Diagnosed Multiple Myeloma Clinical Trial

Official title:

Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324266
• Other study ID #: 2023NZKY-044-02
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Jinling Hospital, China
• Contact: Zhao Qian
• Phone: 18251835035
• Email: 540598707[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Multiple Myeloma

Intervention

Drug:
• Cyclophosphamide
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.
• Lenalidomide
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

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS1	Progression-free Survival 1	3 years
Secondary	Incidence of Efficacy as assessed by IMWG	Efficacy assessed by IMWG	3 years
Secondary	Incidence of Safety as assessed by CTCAE 4.0	Safety assessed by CTCAE 4.0	3 years