NCT05866757

Discontinuation Study

Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Up to 70 patients over 18 years of age who have a diagnosis of Multiple Myeloma and have completed at least 2 years of maintenance therapy. Participants would be divided in two groups: Group 1. Patients with detectable disease who have not achieved CR or VGPR as per IMWG criteria and/or detectable MRD and/or high risk features detectable disease, failed to achieve Complete Remission (CR) or Very Good Partial Remission (VGPR) continuing on maintenance therapy. Group 2. Patients who meet International Myeloma working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Patients who have achieved sustained MRD negative remission by next generation flow cytometry (NGF),defined by IMWG as MRD-negative at two time points that are at least 1 year apart, To the participants in this group will be offered to discontinue maintenance therapy, and it will be further divided in the following subgroups: Subgroup A) Patients who are willing to continue maintenance therapy. Subgroup B) Patients who are willing to discontinue maintenance therapy and continue monitoring. This subgroup will also include 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. The number of the study participants will be limited by the number of patients treated in Cork University Hospital who are meeting inclusion criteria.

Conditions

• Multiple Myeloma
• Cancer
• Hematologic Cancer

Interventions

Type	Name	Description
OTHER	Discontinuation of maintenance treatment	The discontinuation of maintenance treatment in multiple myeloma. Classed as interventional due to treatment being taken away.

Timeline

• Start date: 2023-08-28
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2023-05-19
• Last updated: 2026-03-04

Locations

1 site across 1 country: Ireland