Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Discontinue maintenance therapy SOC.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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) patients. Patients will be eligible if they have a diagnosis of active MM, have completed at least 2 years of maintenance therapy post-ASCT, and meet International Myeloma Working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Once eligibility is confirmed and informed consent is signed, MRD testing will be performed on routine bone marrow aspirate using standard of care next-generation sequencing (NGS) testing and will be defined at a threshold of 10-6. Patients who are in VGPR or CR and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) will go on to discontinue maintenance therapy. MRD-positive patients will continue to be treated as per standard of care (i.e., continue maintenance). Both MRD-positive and MRD-negative patients will be followed as per standard of care for progression using IMWG criteria and for MRD. Quality of life will be assessed at baseline and at 3 months after discontinuing maintenance therapy in MRD-negative patients and at baseline and at the time of next follow-up after MRD testing in MRD-positive patients. In patients who stop maintenance therapy, MRD status will be re-assessed by yearly bone marrow aspirate as per standard of care. Treatment for relapsed/ refractory myeloma will be instituted at the treating physician's discretion for documented clinical and/or biochemical progression. For all patients, a 5-mL peripheral blood and bone marrow sample will be collected and stored at the time of each standard of care bone marrow biopsy and at time of documented disease progression for correlative testing.
Interventions
- Other Discontinue maintenance therapy SOC
MRD testing through NGS Clonoseq will be performed as standard of care on all bone marrow samples. MRD negativity will be defined as observation of no templates at a sensitivity of 1 in a 1,000,000 (10-6) cells assessed, with a minimum of 1 million cells undergoing assessment. In addition, patients must be in VGPR/CR/PR as defined previously.
Primary outcome measures
- Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy [Time frame: 12 months after stopping maintenance therapy]
Secondary outcome measures (12)
- Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy [Time frame: 2 years after stopping maintenance therapy]
- Number of participants that relapse per IMWG at 1 year after stopping maintenance therapy [Time frame: 1 year after stopping maintenance therapy]
- Number of participants that relapse per IMWG at 2 years after stopping maintenance therapy [Time frame: 2 years after stopping maintenance therapy]
- Progression-free survival (PFS) in multiple myeloma patients [Time frame: I year]
- Progression-free survival (PFS) in multiple myeloma patients [Time frame: 2 years]
- Progression-free survival (PFS) in multiple myeloma patients [Time frame: 3 years]
- Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy [Time frame: Baseline]
- Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy [Time frame: 3 months]
- Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response [Time frame: 1 year]
- Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response [Time frame: 2 years]
- Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response [Time frame: 3 years]
- Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Illinois Cancer Center — Chicago
Identifiers
NCT: NCT05192122 · 2021-1196