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

NCT ID: NCT06324266

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-16
• Study Completion Date: 2025-12-31

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.

Conditions

Newly Diagnosed Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm CTX

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

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

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.

arm Len

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

Group Type: PLACEBO_COMPARATOR

Lenalidomide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

CTX; Len

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Feng Li

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Feng, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology of Jinling Hospital

Locations

Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhao Qian

Role: CONTACT

540598707@qq.com

18251835035

Facility Contacts

Zhao Qian

Role: primary

540598707@qq.com

18251835035

Other Identifiers

2023NZKY-044-02

Identifier Type: -

Identifier Source: org_study_id