Assessing the effects of stopping maintenance therapy in multiple myeloma patients
Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features
This study is testing whether stopping maintenance therapy helps people with multiple myeloma who have had no signs of the disease for a while, by comparing their health to those who keep taking the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College Cork Academic / other |
| Locations | 1 site (Cork, Ireland) |
| Trial ID | NCT05866757 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the risk of disease progression in patients with multiple myeloma who have achieved sustained minimal residual disease (MRD) negativity after at least two years of maintenance therapy. Participants will be divided into two groups based on their response to treatment, with one group continuing maintenance therapy and the other group discontinuing it while being closely monitored. The primary endpoint is to measure the rates of sustained MRD negativity in the bone marrow at 12 months after stopping maintenance therapy. The study aims to include up to 70 patients from Cork University Hospital who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with multiple myeloma who have completed at least two years of maintenance therapy and achieved sustained MRD negativity.
Not a fit: Patients who have not achieved sustained MRD negativity or have high-risk features may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine whether some patients can safely discontinue maintenance therapy without risking disease progression.
How similar studies have performed: Other studies have explored similar approaches in multiple myeloma, but this specific discontinuation strategy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or over 2. 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). 3. Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission 4. 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 5. 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: 1. 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.. 2. 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… 3. Prior organ transplant or condition requiring immunosuppressive therapy. 4. Prior allogenic haematopoietic cell transplant 5. Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy. 6. Unable to sign an informed consent form.
Where this trial is running
Cork, Ireland
- Cork University Hospital — Cork, Ireland, Ireland (Recruiting)
Study contacts
- Study coordinator: Dr Vitaliy Mykytiv
- Email: vitaliy.mykytiv@hse.ie
- Phone: 00353214922000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.