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

March 15, 2024 updated by: Feng Li, Jinling Hospital, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jinling Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm CTX
Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years
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.
Other Names:
  • CTX
Placebo Comparator: arm Len
Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two 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.
Other Names:
  • Len

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS1
Time Frame: 3 years
Progression-free Survival 1
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Efficacy as assessed by IMWG
Time Frame: 3 years
Efficacy assessed by IMWG
3 years
Incidence of Safety as assessed by CTCAE 4.0
Time Frame: 3 years
Safety assessed by CTCAE 4.0
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Li Feng, Doctor, Department of Hematology of Jinling Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023NZKY-044-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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