Stopping maintenance therapy in patients with minimal residual disease-negative multiple myeloma

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 pilot study evaluates the safety and risk of disease progression in patients with minimal residual disease (MRD)-negative multiple myeloma who discontinue maintenance therapy after undergoing autologous stem cell transplant (ASCT). Eligible participants must have completed at least two years of maintenance therapy and achieved a very good partial response or complete response. The study involves MRD testing through next-generation sequencing to confirm eligibility, followed by monitoring for disease progression and quality of life assessments. Patients who remain MRD-positive will continue standard maintenance therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ECOG Performance Status equal to or less than 2 within 30 days prior to registration
* Revised International Staging System (R-ISS) I,2 or 3
* Patients with multiple myeloma as defined by IMWG
* Received at least 2 years of post ASCT maintenance (patients may have received any number of prior lines of therapy).
* Maintenance therapy is defined as any anti-myeloma therapy initiated after ASCT to prevent disease recurrence and prolong time in remission (i.e., lenalidomide, bortezomib, RVD, etc.)
* Disease response is VGPR or CR at the time of enrollment as defined by IMWG criteria.
* Patients or their legally authorized representative 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:

* Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome
* Prior organ transplant or condition requiring immunosuppressive therapy
* Prior allogeneic hematopoietic cell transplant
* Treatment with any investigational drug within 30 days prior to enrollment
* Unable to sign an informed consent or their legally authorized represnetative

Where it's running

• University of Illinois Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Karen Sweiss, PhamD — University of Illinois Chicago
• Study coordinator: Karen Sweiss, PharmD
• Email: ksweis2@uic.edu
• Phone: 312-996-0875

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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.