Discontinuation Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College Cork
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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..
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…
Prior organ transplant or condition requiring immunosuppressive therapy.
Prior allogenic haematopoietic cell transplant
Trial design
Design model
Parallel
Treatments tested in this trial
Discontinuation of maintenance treatment
Other interventionThe discontinuation of maintenance treatment in multiple myeloma. Classed as interventional due to treatment being taken away.
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: Continuation - Group 1: Detectable diseaseNo intervention 0 interventions
Group B: Continuation - Group 2 Subgroup A: RemissionNo intervention 0 interventions
Group C: Discontinuation - Group 2 Subgroup BOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Number
Time frame
12 monthsSecondary outcomes
1
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 24 months after discontinuation of maintenance therapy.
Number
Time frame
24 months2
Progression-free survival in multiple myeloma patients at 1 year in both groups of patients (on maintenance therapy and those who have discontinued)
Number
Time frame
1 year3
Progression-free survival in multiple myeloma patients at 2 years in both groups of patients (on maintenance therapy and those who have discontinued)
Number
Time frame
2 years4
Compare health-related quality of life between MM patients discontinuing versus continuing maintenance therapy using a QOL questionnaire. The EoRTC QLQ - MY20 will be used. Minimum value 50, maximum value 200. Lower values indicate better outcomes.
Questionnaire
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College Cork
Lead sponsor
Cancer Research@UCC
Collaborator
Source ClinicalTrials.gov