Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05866757

Discontinuation Study

Led by University College Cork · Updated on 2026-03-04

70

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

C

Cancer Research@UCC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Discontinuation Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or over
  • Diagnosis of multiple myeloma as first line of treatment
  • Completed at least 2 years of maintenance therapy to prevent disease recurrence
  • Patients who stopped maintenance earlier than 2 years due to side effects but have sustained MRD negative complete remission
  • Able and willing to sign informed consent and follow study schedule
Not Eligible

You will not qualify if you...

  • Received more than one line of therapy or not completed two years of maintenance unless discontinued early with sustained MRD negative remission
  • Diagnosed with other plasma cell disorders such as lymphoplasmacytic lymphoma, Waldenstrom macroglobulinemia, AL amyloidosis, or POEMS syndrome
  • History of organ transplant or need for immunosuppressive therapy
  • Prior allogenic hematopoietic cell transplant
  • Treatment with investigational therapy not including maintenance
  • Unable to sign informed consent form

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cork University Hospital

Cork, Ireland, Ireland

Actively Recruiting

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Research Team

D

Dr Vitaliy Mykytiv

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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