Clinical trial · Interventional
Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation
Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation
NCT06324266CI-TRIAL-00075285unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- arm CTX
- description
- Cyclophosphamide monotherapy: CTX, 0.1g×7days,1/every other week, 28 days per course of treatment,total two years
- interventionNames
- Drug: Cyclophosphamide
- type
- PLACEBO_COMPARATOR
- label
- arm Len
- description
- Lenalidomide monotherapy:Len,10mg/day×21days, 28 days per course of treatment,total two years
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- PFS1
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.