Low-dose cyclophosphamide and lenalidomide for maintenance therapy in multiple myeloma

Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation

This study is testing if a combination of low-dose cyclophosphamide and lenalidomide can help people with newly diagnosed multiple myeloma who can't have a transplant stay healthy longer after their initial treatment.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06324266 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of low-dose cyclophosphamide and lenalidomide as maintenance therapy for patients with newly diagnosed multiple myeloma who are unsuitable for transplantation. The study involves randomized and controlled clinical studies focusing on patients in the standard-risk group who have achieved a very good partial response (VGPR) or better after initial treatment. Participants will receive maintenance therapy for a duration of two years to assess the long-term benefits and safety of these medications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed multiple myeloma in the standard-risk group who have achieved VGPR or better after initial therapy.

Not a fit: Patients with high-risk cytogenetics, recurrent or refractory multiple myeloma, or those who did not achieve VGPR or better prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance therapy option for patients with multiple myeloma who cannot undergo transplantation.

How similar studies have performed: Other studies have explored maintenance therapies for multiple myeloma, but the specific combination of low-dose cyclophosphamide and lenalidomide in this context is relatively novel.

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.

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Li Feng, Doctor — Department of Hematology of Jinling Hospital
• Study coordinator: Zhao Qian

Conditions Newly Diagnosed Multiple Myeloma