Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual D… (NCT05192122) | Clinical Trial Compass
RecruitingPhase 1
Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD
United States50 participantsStarted 2021-12-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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