Stopping Maintenance Therapy in People With Multiple Myeloma in MRD-Negative Remission

Last updated: January 30, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Hematologic Cancer

Red Blood Cell Disorders

Treatment

Cessation of continuous matinenace therapy

Clinical Study ID

NCT04221178
19-422
  • Ages > 18
  • All Genders

Study Summary

This study will test whether stopping maintenance therapy in people with multiple myeloma in MRD-negative remission has the same effect on disease control as continuing this therapy. The study will look at whether people currently on maintenance therapy can safely stop this treatment and continue with active surveillance instead while keeping their MRD-negative remission status for at least 1 year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with plasma cell myeloma treated with any number of prior lines of therapy,who at the time of study enrollment have had sustained MRD-negativity at a giventimepoint and a subsequent time point with an interval of 3 or more years while oncontinuous maintenance therapy. MRD-negativity is defined per the InternationalMyeloma Working Group Consensus Panel.

  • MRD positivity will be defined by detection of 1 or more neoplastic plasma cells in 10^5 nucleated cells by flow cytometry as per IMWG criteria (i.e., sensitivity of 10-5)

  • Age >/= 18 years with ECOG performance status </= 2

  • Patients must be able to understand and be willing to sign a voluntary informedconsent form and agree to compliance with the protocol schedule; with the knowledgethat they may withdraw consent at any time without impact on future medical care

Exclusion

Exclusion Criteria:

  • Patients found to be MRD-positive at time of screening

  • Patients with plasma cell leukemia or other disorder of plasma cell neoplasm

  • Patient who are receiving other therapy with the intent of treating myeloma with theexception of bisphosphonates

  • Patients being treated for another, potentially life-limiting malignancy with 3-yearlead-in to study enrollment, with the exception of non-melanoma skin cancer or insitu malignancy or malignancies that have received definitive curative therapy

  • Prior organ transplant or condition requiring immunosuppressive therapy

  • Prior allogeneic hematopoietic cell transplant

  • Patients with any other ongoing, concomitant, comorbid illness including but notlimited to uncontrolled diabetes, NYHA class III or IV heart failure, uncontrolledcoronary artery disease/arrhythmia, psychiatric or social disorder that wouldcompromise compliance with the study schema

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Cessation of continuous matinenace therapy
Phase:
Study Start date:
January 03, 2020
Estimated Completion Date:
January 03, 2026

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York 11553
    United States

    Active - Recruiting

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