Stopping maintenance therapy in patients with minimal residual disease-negative multiple myeloma
Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial): A Pilot Study of Minimal Residual Disease (MRD)-Driven Discontinuation of Maintenance (HEME-20)
This study is testing whether patients with minimal residual disease-negative multiple myeloma can safely stop their maintenance therapy after a stem cell transplant to see how it affects their health and quality of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05192122 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with multiple myeloma who are MRD-negative after at least two years of maintenance therapy post-ASCT.
Not a fit: Patients with MRD-positive status or those with other serious conditions like plasma cell leukemia or AL amyloidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow certain patients to safely discontinue maintenance therapy, potentially reducing treatment burden and side effects.
How similar studies have performed: While this approach is novel in assessing the discontinuation of maintenance therapy in MRD-negative patients, similar studies have shown promising results in managing multiple myeloma.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- University of Illinois Cancer Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Karen Sweiss, PhamD — University of Illinois at Chicago
- Study coordinator: Karen Sweiss, PharmD
- Email: ksweis2@uic.edu
- Phone: 312-996-0875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.