Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06324266
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jinling Hospital, China
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Li Feng, Doctor
Principal Investigator Affiliation	Department of Hematology of Jinling Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Newly Diagnosed Multiple Myeloma

Additional Details

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.

Arms & Interventions

Arms

Experimental: arm CTX

Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years

Placebo Comparator: arm Len

Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years

Interventions

Drug: - Cyclophosphamide

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.

Drug: - Lenalidomide

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Jinling Hospital, Nanjing, Jiangsu, China

Status

Recruiting

Address

Jinling Hospital

Nanjing, Jiangsu,

Site Contact

Zhao Qian

540598707@qq.com

18251835035

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