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

NCT06324266 | Recruiting Phase 2 DMC

• 1 other identifier: 2023NZKY-044-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• PFS1

  Progression-free Survival 1

  3 years

Secondary Outcomes (2)

• Incidence of Efficacy as assessed by IMWG

  3 years

• Incidence of Safety as assessed by CTCAE 4.0

  3 years

Study Arms (2)

arm CTX

EXPERIMENTAL

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

Drug: Cyclophosphamide

arm Len

PLACEBO COMPARATOR

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

Drug: Lenalidomide

Interventions

Cyclophosphamide DRUG

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.

Also known as: CTX

arm CTX

Lenalidomide DRUG

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.

Also known as: Len

arm Len

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Secretory MM with measurable indicators;
• Age ≥ 18 years old, gender unlimited;
• No obvious dysfunction of heart, lungs, etc. (≤ Grade I);
• General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).

You may not qualify if:

• Cytogenetic high-risk patients;
• Recurrent or refractory MM;
• Using autologous hematopoietic stem cell transplantation as a consolidation therapy;
• The therapeutic effect did not reach VGPR or above before enrollment;
• Asymptomatic MM;
• No measurable indicators;
• KPS\<50%(excluding those caused by pathological fractures）；
• Dysfunction of heart, lungs, etc. (\> Grade I);
• Unable to cooperate in observing adverse reactions and therapeutic effects;
• Pregnancy, breastfeeding, or refusal of contraception by women;
• There is drug abuse and medical, psychological, or social conditions that may interfere with patients participating in research or evaluating research results;
• Any unstable or potentially endangering patient safety and compliance with the study.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; Lenalidomide; vicilin protein, plant

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Li Feng, Doctor

  Department of Hematology of Jinling Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Qian

CONTACT

18251835035; 540598707@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 21, 2024
• Study Start: April 16, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)