Status:
RECRUITING
Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
This is 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 Multiple Myeloma (MM) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05192122
Start Date
December 31 2021
End Date
January 1 2029
Last Update
December 18 2025
Active Locations (1)
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1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612