Suspended

Maintenance Therapy Cessation Effects in MRD-Negative Multiple Myeloma Remission

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Study Aim

This observational study aims to examine how stopping maintenance therapy affects the progression-free survival in multiple myeloma patients who are in remission and have no detectable minimal residual disease (MRD-negative state) for one year after enrolling in this study.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2020
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2020

Actual date on which the first participant was enrolled.

This study focuses on people with multiple myeloma, a type of blood cancer, who are in a state called MRD-negative remission. This means their cancer is under control and minimal residual disease (MRD) is not detectable. The main goal is to test if stopping maintenance therapy, the ongoing treatment to keep cancer in check, has the same effect on disease control as continuing it. The importance of this study lies in exploring if patients can safely stop maintenance therapy and switch to active surveillance, potentially improving their quality of life while keeping the cancer at bay. In this observational study, participants who are currently on maintenance therapy will stop this treatment and transition to active surveillance. The primary outcome measured is Progression Free Survival, which means maintaining the MRD-negative state for at least one year after enrolling in the study. This will help determine if stopping maintenance therapy is as effective as continuing it for disease control.

Official TitleA Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersNeoplasms, Plasma Cell

Criteria

4 inclusion criteria required to participate
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

7 exclusion criteria prevent from participating
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 or malignancies that have received definitive curative therapy

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Memorial Sloan Kettering Basking Ridge

Basking Ridge, United StatesOpen Memorial Sloan Kettering Basking Ridge in Google Maps
Suspended

Memorial Sloan Kettering Monmouth

Middletown, United States
Suspended

Memorial Sloan Kettering Bergen

Montvale, United States
Suspended

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, United States
Suspended7 Study Centers
Maintenance Therapy Cessation Effects in MRD-Negative Multiple Myeloma Remission | PatLynk