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

A Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions

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.

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Other: Cessation of continuous matinenace therapy

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Alexander Lesokhin, MD; Phone Number: 212-639-3069; Email: lesokhia@mskcc.org
• Study Contact Backup: Name: Neha Korde, MD; Phone Number: 212-639-7664; Email: korden@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Suffolk
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau
      • Contact: Neha Korde, MD; Phone Number: 212-639-7664

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted at MSKCC. Efforts will be made to ensure that women and minority groups are adequately represented in this trial. All patients will be seen by MSKCC myeloma physicians and associated MSKCC co-investigators, enrolled and registered at MSKCC.

Description

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 given timepoint and a subsequent time point with an interval of 3 or more years while on continuous maintenance therapy. MRD-negativity is defined per the International Myeloma 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 informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care

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 the exception of bisphosphonates
• Patients being treated for another, potentially life-limiting malignancy with 3-year lead-in to study enrollment, with the exception of non-melanoma skin cancer or in situ malignancy
• Prior organ transplant or condition requiring immunosuppressive therapy
• Prior allogeneic hematopoietic cell transplant
• Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or IV heart failure, uncontrolled coronary artery disease/arrhythmia, psychiatric or social disorder that would compromise compliance with the study schema

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRD-Negative Participants	Other: Cessation of continuous matinenace therapy; Cessation of maintenance therapy for participants in sustained MRD-negative remission while under careful observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Maintaining a MRD-negative state for one year of enrolling on this study	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Neha Korde, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Estimated): January 3, 2025
• Study Completion (Estimated): January 3, 2025

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Estimated): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Plasma Cell Myeloma; MRD-Negative; MRD-Negative Remission; 19-422
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 19-422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No