Multiple MyelomaNCT05866757
Discontinuation Study
A study testing Discontinuation of maintenance treatment in people with Multiple Myeloma and Cancer, run by University College Cork at 1 site in Ireland.
Trial summary
An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Cancer, Hematologic Cancer
- What is being tested?
- Discontinuation of maintenance treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 28 Aug 2023to Jul 2028
- Phase
- Interventional
- 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
- 18 years of age or over
- Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study).
- Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission
- Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included
- Patients 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 who have received more than one line of therapy (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study) or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission..
- Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc…
- Prior organ transplant or condition requiring immunosuppressive therapy.
- Prior allogenic haematopoietic cell transplant
- Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy.
- Unable to sign an informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Cork University Hospital
Cork, Ireland
Dr Vitaliy Mykytiv, 00353214922000, vitaliy.mykytiv@hse.ie
Vitaliy Mykytiv
About this study
Official title: Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features
An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Read the detailed description
Up to 70 patients over 18 years of age who have a diagnosis of Multiple Myeloma and have completed at least 2 years of maintenance therapy.
Participants would be divided in two groups: Group 1. Patients with detectable disease who have not achieved CR or VGPR as per IMWG criteria and/or detectable MRD and/or high risk features detectable disease, failed to achieve Complete Remission (CR) or Very Good Partial Remission (VGPR) continuing on maintenance therapy. Group 2. Patients who meet International Myeloma working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Patients who have achieved sustained MRD negative remission by next generation flow cytometry (NGF),defined by IMWG as MRD-negative at two time points that are at least 1 year apart, To the participants in this group will be offered to discontinue maintenance therapy, and it will be further divided in the following subgroups: Subgroup A) Patients who are willing to continue maintenance therapy. Subgroup B) Patients who are willing to discontinue maintenance therapy and continue monitoring. This subgroup will also include patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included.
The number of the study participants will be limited by the number of patients treated in Cork University Hospital who are meeting inclusion criteria.
- Conditions
- Multiple Myeloma, Cancer, Hematologic Cancer
- Being tested
- Discontinuation of maintenance treatment
- Keywords
- Multiple Myeloma, Cancer
- Medical subject headings
- Multiple Myeloma, Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of maintenance treatmentOther
The discontinuation of maintenance treatment in multiple myeloma. Classed as interventional due to treatment being taken away.
| Study group | Role | What they receive |
|---|---|---|
| Continuation - Group 1: Detectable disease | No intervention | Continuing Maintenance Therapy- Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed. |
| Continuation - Group 2 Subgroup A: Remission | No intervention | Continuing Maintenance Therapy- Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features. High-risk cytogenetics abnormalities defined as per IMWG criteria (del(17p) and/or t(4;14) and/or t(14;16)) , or any other features suggestive of high risk disease: extramedullary disease, poor response to first line therapy, plasma cell leukaemia, organomegaly secondary to infiltration by multiple myeloma. Maintenance will continue until disease progression, monitored every 3 months as per SOC or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed. |
| Discontinuation - Group 2 Subgroup B | Other | Patients who prefer to discontinue maintenance therapy. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included in this subgroup. This subgroup will be monitored and per SOC with blood tests, and BM MRD by NGF. In case of detectable disease in any of the samples (blood or BM) they will be offered to restart on maintenance therapy. Changing to a different type of treatment could be also offered to these patients, after discussion with treating physician. In case of being switched to a different treatment patient will withdraw from the study. QOL will be assessed Receives: Other: Discontinuation of maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Number
Measured: 12 months
Secondary outcomes (4)
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 24 months after discontinuation of maintenance therapy.
Number
Measured: 24 months
Progression-free survival in multiple myeloma patients at 1 year in both groups of patients (on maintenance therapy and those who have discontinued)
Number
Measured: 1 year
Progression-free survival in multiple myeloma patients at 2 years in both groups of patients (on maintenance therapy and those who have discontinued)
Number
Measured: 2 years
Compare health-related quality of life between MM patients discontinuing versus continuing maintenance therapy using a QOL questionnaire. The EoRTC QLQ - MY20 will be used. Minimum value 50, maximum value 200. Lower values indicate better outcomes.
Questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start28 Aug 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (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.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided in the following groups: Group 1: Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. Group 2: Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features This group will be divided in the following subgroups: Subgroup A: Patients who prefer to continue on maintenance therapy. Maintenance will continue until disease progression. Subgroup B: Patients who prefer to discontinue maintenance therapy.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research@UCC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866757
- Sponsor's protocol ID
- 22107
- Status last verified
- Mar 2026
- First submitted
- 10 May 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features
- ClinicalTrials.gov ID
- NCT05866757
- Acronym / sponsor ID
- 22107
- Conditions
- Multiple Myeloma, Cancer, Hematologic Cancer
- Keywords
- Multiple Myeloma, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Cancer Research@UCC
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 May 2023 (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.
An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Detailed description
Up to 70 patients over 18 years of age who have a diagnosis of Multiple Myeloma and have completed at least 2 years of maintenance therapy.
Participants would be divided in two groups: Group 1. Patients with detectable disease who have not achieved CR or VGPR as per IMWG criteria and/or detectable MRD and/or high risk features detectable disease, failed to achieve Complete Remission (CR) or Very Good Partial Remission (VGPR) continuing on maintenance therapy. Group 2. Patients who meet International Myeloma working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Patients who have achieved sustained MRD negative remission by next generation flow cytometry (NGF),defined by IMWG as MRD-negative at two time points that are at least 1 year apart, To the participants in this group will be offered to discontinue maintenance therapy, and it will be further divided in the following subgroups: Subgroup A) Patients who are willing to continue maintenance therapy. Subgroup B) Patients who are willing to discontinue maintenance therapy and continue monitoring. This subgroup will also include patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included.
The number of the study participants will be limited by the number of patients treated in Cork University Hospital who are meeting inclusion criteria.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be divided in the following groups: Group 1: Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. Group 2: Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features This group will be divided in the following subgroups: Subgroup A: Patients who prefer to continue on maintenance therapy. Maintenance will continue until disease progression. Subgroup B: Patients who prefer to discontinue maintenance therapy.
| Arm | Type | Receives |
|---|---|---|
| Continuation - Group 1: Detectable disease | No intervention | –Continuing Maintenance Therapy- Patients with biochemically detectable disease who have failed to achieve Complete remission (CR) or Very good Partial Remission (VGPR) by IMWG criteria and/or MRD-positive and/or high risk features. They will continue maintenance therapy until disease progression with monitoring every 3 months as per standard of care (SOC), or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed. |
| Continuation - Group 2 Subgroup A: Remission | No intervention | –Continuing Maintenance Therapy- Patients in biochemical remission, who meet IMWG criteria for very good partial response (VGPR) or complete response (CR and and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) without high risk features. High-risk cytogenetics abnormalities defined as per IMWG criteria (del(17p) and/or t(4;14) and/or t(14;16)) , or any other features suggestive of high risk disease: extramedullary disease, poor response to first line therapy, plasma cell leukaemia, organomegaly secondary to infiltration by multiple myeloma. Maintenance will continue until disease progression, monitored every 3 months as per SOC or more often if required. In case of disease progression these patients will be switched to a different treatment and withdraw from the study. QOL will be assessed. |
| Discontinuation - Group 2 Subgroup B | Other | Other: Discontinuation of maintenance treatmentPatients who prefer to discontinue maintenance therapy. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included in this subgroup. This subgroup will be monitored and per SOC with blood tests, and BM MRD by NGF. In case of detectable disease in any of the samples (blood or BM) they will be offered to restart on maintenance therapy. Changing to a different type of treatment could be also offered to these patients, after discussion with treating physician. In case of being switched to a different treatment patient will withdraw from the study. QOL will be assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or over
- Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study).
- Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission
- Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included
- Patients 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.
Key exclusion criteria (6 listed)
- Patients who have received more than one line of therapy (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study) or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission..
- Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc…
- Prior organ transplant or condition requiring immunosuppressive therapy.
- Prior allogenic haematopoietic cell transplant
- Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy.
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 |
|---|---|---|
| Discontinuation of maintenance treatmentThe discontinuation of maintenance treatment in multiple myeloma. Classed as interventional due to treatment being taken away. | Other | Discontinuation - Group 2 Subgroup B |
Primary outcome
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.
Time frame: 12 months
Number
4 secondary outcomes
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 24 months after discontinuation of maintenance therapy.
Time frame: 24 months
Progression-free survival in multiple myeloma patients at 1 year in both groups of patients (on maintenance therapy and those who have discontinued)
Time frame: 1 year
Progression-free survival in multiple myeloma patients at 2 years in both groups of patients (on maintenance therapy and those who have discontinued)
Time frame: 2 years
Compare health-related quality of life between MM patients discontinuing versus continuing maintenance therapy using a QOL questionnaire. The EoRTC QLQ - MY20 will be used. Minimum value 50, maximum value 200. Lower values indicate better outcomes.
Time frame: 2 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 4 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of maintenance treatment in people with Multiple Myeloma and Cancer, run by University College Cork at 1 site in Ireland.
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 5 inclusion and 6 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 4 Mar 2026. 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 Ireland. 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.
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 Dr Vitaliy Mykytiv (00353214922000, vitaliy.mykytiv@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that remain in sustained MRD negative remission by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy. (time frame: 12 months). 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 4 Mar 2026.