NCT05192122RecruitingPhase 1
Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD
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)
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
A pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative MM patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Jan 2022
- Start date
- 31 Dec 2021
- Primary completion date
- Jan 2029
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Multiple myeloma
- NCT number
- NCT05192122
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 31 Dec 2021 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior organ transplant or condition requiring immunosuppressive therapy
- Prior allogeneic hematopoietic cell transplant
- Treatment with any investigational drug within 30 days prior to enrollment
Other illness
- Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome
Other
- Unable to sign an informed consent or their legally authorized represnetative
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.