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
- Diseases
- Multiple myeloma
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center @ Suffolk Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.