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Trial Title:
Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation
NCT ID:
NCT06324266
Condition:
Newly Diagnosed Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Cyclophosphamide
Lenalidomide
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
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 group label:
arm CTX
Other name:
CTX
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
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.
Arm group label:
arm Len
Other name:
Len
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinling Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhao Qian
Phone:
18251835035
Email:
540598707@qq.com
Start date:
April 16, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Jinling Hospital, China
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06324266
