Assessing the effects of stopping maintenance therapy in multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cork University Hospital
  Cork, Ireland, Ireland Recruiting

Study contacts

• Study coordinator: Dr Vitaliy Mykytiv
• Email: vitaliy.mykytiv@hse.ie
• Phone: 00353214922000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.