A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

Last updated: July 3, 2024
Sponsor: FengYan Jin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Cancer

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT06109233
MRD 2023
  • Ages > 18
  • All Genders

Study Summary

The aim of this study was to observe the rate of MRD conversion and the impact on survival in newly diagnosed multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) who were switched to high-intensity therapy, and to compare the rate of persistent MRD-negativity, progression-free survival (PFS), and overall survival (OS) between the two groups in comparison with NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be at least 18 years of age.

  2. Subject must have documented newly diagnosed symptomatic multiple myeloma as definedby 2014 International Myeloma Working Group criteria.

  3. Subject must have achieved a response (partial response [PR] or better based oninvestigator's determination of response by the IMWG criteria) to at one priorregimen.

  4. Women of childbearing potential must commit to either abstain continuously fromheterosexual sexual intercourse or to use 2 methods of reliable birth controlsimultaneously. Contraception must begin 4 weeks prior to dosing and continue untilat least 3 months after receiving the last dose of the study drug. A woman ofchildbearing potential must have a negative serum or urine pregnancy tests atscreening within 14 days prior to randomization.

  5. Each subject (or their legally acceptable representative) must sign an informedconsent form (ICF) indicating that he or she understands the purpose of andprocedures required for the study and are willing to participate in the study.

Exclusion

Exclusion Criteria:

  1. Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy ofundetermined significance, or smoldering multiple myeloma. Monoclonal gammopathy ofundetermined significance is defined by presence of serum M-protein <3 g/dL; absenceof lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to theM-protein; and (if determined) proportion of plasma cells in the bone marrow of 10%or less. Smoldering multiple myeloma is defined as asymptomatic multiple myelomawith absence of related organ or tissue impairment or end-organ damage.

  2. Relapsed and refractory myeloma:Relapsed and refractory myeloma is defined asdisease that is nonresponsive while on salvage therapy, or progresses within 60 daysof last therapy in patients who have achieved minimal response (MR) or better atsome point previously before then progressing in their disease course.

  3. Primary refractory myeloma:Primary refractory myeloma is defined as disease that isnonresponsive in patients who have never achieved a minimal response or better withany therapy.

  4. Subject is known or suspected of not being able to comply with the study protocol。Subject has any condition for which, in the opinion of the investigator,participation would not be in the best interest of the subject or that couldprevent, limit, or confound the protocol-specified assessments.

Study Design

Total Participants: 80
Study Start date:
January 10, 2022
Estimated Completion Date:
January 10, 2026

Study Description

There is still an unmet clinical need as to whether NDMM patients with persistent MRD positive would benefit from switching to high-intensity therapy. The induction regimen (Dara+/- (Vd, Rd, Pd, VRd, VPd)) was selected based on the frail or high-risk status of NDMM patients. Transplantation or consolidation and maintenance regimens were adjusted by MRD status detected by NGF.

Connect with a study center

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.