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The FREEDMM Trial: Stopping Maintenance Therapy in Multiple Myeloma

This study, called The FREEDMM Trial, is for people with multiple myeloma who have had an autologous stem cell transplant (ASCT) and have been on maintenance therapy for at least two years. It's looking at whether it's safe to stop maintenance therapy if your body shows no signs of minimal residual disease (MRD). MRD means there are very few myeloma cells left after treatment, detected by a sensitive test called NGS Clonoseq. To join, you must have an ECOG Performance Status of 2 or less, and your myeloma must be in a very good partial response (VGPR) or complete response (CR). The main goal is to see how many participants remain free from disease progression for 12 months after stopping maintenance therapy.

Study design
This is an interventional pilot study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo MRD testing on bone marrow samples. If you are MRD-negative at two time points at least one year apart, you would discontinue maintenance therapy. You would be followed for disease progression and quality of life assessments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease progression using IMWG criteria and for MRD. The primary endpoint is measured at 12 months after stopping maintenance therapy.

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NCT05192122

Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Illinois at Chicago
~50 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Discontinue maintenance therapy SOC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy
Measured over 12 months after stopping maintenance therapy

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Karen Sweiss, PhamD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Karen Sweiss, PharmD
[email protected]
312-996-0875
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy12 months after stopping maintenance therapy

    Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy (MRD defined as 10-6)