Clinical trial · Interventional
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)
NCT05192122CI-TRIAL-00099284HEME-20recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Discontinue maintenance therapy SOC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Bone marrow MRD-negative VGPR or CR
- description
- Discontinue maintenance therapy after at least three years
- interventionNames
- Other: Discontinue maintenance therapy SOC
- type
- OTHER
- label
- Bone marrow MRD-positive VGPR or CR
- description
- Continue maintenance therapy as per SOC
- interventionNames
- Other: Discontinue maintenance therapy SOC
Primary outcomes (1)
- measure
- Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy
- timeFrame
- 12 months after stopping maintenance therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.