Stopping Maintenance Treatment in Multiple Myeloma Patients Without High-Risk Features
Studies whether stopping maintenance therapy is safe for adults with multiple myeloma in remission.
Plain-language title generated from the registry record
Registry title: Discontinuation Study
Key facts
- Where
- Cork, IrelandSee the site
Where in Ireland
- Cork University HospitalCork, IrelandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University College Cork
- Trial code
- NCT05866757
- Record updated
- 4 March 2026
- Original description
An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.Read full original descriptionShow less
Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features
An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Inclusion: 18 years of age or over; Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study); Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission; Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included; 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: Patients who have received more than one line of therapy (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study) or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission; Prior organ transplant or condition requiring immunosuppressive therapy; Prior allogenic haematopoietic cell transplant; Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy; Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc…; Unable to sign an informed consent form.