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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 CTX as Maintenance Therapy for MM Unsuitable for Transplantation

Recruiting
18 years and older
All
Phase 2/3

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Overview

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.

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.

Study details
    Newly Diagnosed Multiple Myeloma

NCT06324266

Jinling Hospital, China

31 August 2025

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