Multiple MyelomaPhase 1HEME-20NCT05192122
Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD
A Phase 1 study testing Discontinue maintenance therapy SOC in people with Multiple Myeloma, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Discontinue maintenance therapy SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Karen Sweiss, PharmD, 312-996-0875, ksweis2@uic.edu
About this study
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)
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Discontinue maintenance therapy SOC
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinue maintenance therapy SOCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow MRD-negative VGPR or CR | Other | Discontinue maintenance therapy after at least three years Receives: Other: Discontinue maintenance therapy SOC |
| Bone marrow MRD-positive VGPR or CR | Other | Continue maintenance therapy as per SOC Receives: Other: Discontinue maintenance therapy SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy
Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy (MRD defined as 10-6)
Measured: 12 months after stopping maintenance therapy
Secondary outcomes (14)
Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy
Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy (MRD defined as 10-6)
Measured: 2 years after stopping maintenance therapy
Number of participants that relapse per IMWG at 1 year after stopping maintenance therapy
Number of participants that relapse per IMWG
Measured: 1 year after stopping maintenance therapy
Number of participants that relapse per IMWG at 2 years after stopping maintenance therapy
Number of participants that relapse per IMWG
Measured: 2 years after stopping maintenance therapy
Progression-free survival (PFS) in multiple myeloma patients
PFS in multiple myeloma patients at 1 year
Measured: I year
Progression-free survival (PFS) in multiple myeloma patients
PFS in multiple myeloma patients at 2 years
Measured: 2 years
Progression-free survival (PFS) in multiple myeloma patients
PFS in multiple myeloma patients at 3 years
Measured: 3 years
Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy
Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy therapy using the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma questionnaire (EORTC QLQ-MY20) questionnaire
Measured: Baseline
Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy
Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy using the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma questionnaire (EORTC QLQ-MY20) questionnaire
Measured: 3 months
Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response
Measuring the disease response
Measured: 1 year
Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response
Measuring the disease response
Measured: 2 years
Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response
Measuring the disease response
Measured: 3 years
Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response
PFS in multiple myeloma patients at 1 year
Measured: 1 year
Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response
PFS in multiple myeloma patients at 2 years
Measured: 2 years
Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response
PFS in multiple myeloma patients at 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start31 Dec 2021
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with sustained MRD negativity (defined as MRD negative at 2 time points, at least 12 months apart) will stop maintenance therapy. Bone marrow MRD testing must be performed at UIC prior to study entry can be counted as the first time point as long as the patient has received at least 2 years of maintenance at the time of MRD testing. These patients will then be monitored for sustained MRD-negativity after stopping therapy.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Sweiss, University of Illinois Chicago
- Investigators
- Karen Sweiss, PhamD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192122
- Sponsor's protocol ID
- 2021-1196
- Acronym
- HEME-20
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05192122
- Acronym / sponsor ID
- HEME-20 / 2021-1196
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with sustained MRD negativity (defined as MRD negative at 2 time points, at least 12 months apart) will stop maintenance therapy. Bone marrow MRD testing must be performed at UIC prior to study entry can be counted as the first time point as long as the patient has received at least 2 years of maintenance at the time of MRD testing. These patients will then be monitored for sustained MRD-negativity after stopping therapy.
| Arm | Type | Receives |
|---|---|---|
| Bone marrow MRD-negative VGPR or CR | Other | Other: Discontinue maintenance therapy SOCDiscontinue maintenance therapy after at least three years |
| Bone marrow MRD-positive VGPR or CR | Other | Other: Discontinue maintenance therapy SOCContinue maintenance therapy as per SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinue maintenance therapy SOCMRD 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. | Other | Bone marrow MRD-negative VGPR or CR, Bone marrow MRD-positive VGPR or CR |
Primary outcome
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
Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy (MRD defined as 10-6)
14 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Sweiss, PhamD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Discontinue maintenance therapy SOC in people with Multiple Myeloma, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Sweiss, PharmD (312-996-0875, ksweis2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.