Newly Diagnosed Multiple Myeloma
Conditions
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.
Interventions
DRUGCyclophosphamide
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.
DRUGLenalidomide
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.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS1 | 3 years | Progression-free Survival 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactZhao Qian
Outcome results
None listed