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NCT04221178Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 10 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
50 (actual)
First submitted
6 Jan 2020
Start date
3 Jan 2020
Primary completion date
3 Jan 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT04221178

What you commit to

  • Study type: Observational
  • Participants enrolled: 50
  • From 3 Jan 2020 to the primary completion date, 3 Jan 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

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

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Suffolk
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Bergen
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering Nassau
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.