Plasma Cell MyelomaNCT04221178
Stopping Maintenance Therapy in People With Multiple Myeloma in MRD-Negative Remission
An observational study of Plasma Cell Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
This study will test whether stopping maintenance therapy in people with multiple myeloma in MRD-negative remission has the same effect on disease control as continuing this therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Cessation of continuous matinenace therapy
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Jan 2020to 3 Jan 2027
- Phase
- Observational
- 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
Study population: This study will be conducted at MSKCC. Efforts will be made to ensure that women and minority groups are adequately represented in this trial. All patients will be seen by MSKCC myeloma physicians and associated MSKCC co-investigators, enrolled and registered at MSKCC.
Who may be able to join
- Patients with plasma cell myeloma treated with any number of prior lines of therapy, who at the time of study enrollment have had sustained MRD-negativity at a given timepoint and a subsequent time point with an interval of 3 or more years while on continuous maintenance therapy. MRD-negativity is defined per the International Myeloma Working Group Consensus Panel.
- MRD positivity will be defined by detection of 1 or more neoplastic plasma cells in 10^5 nucleated cells by flow cytometry as per IMWG criteria (i.e., sensitivity of 10-5)
- Age >/= 18 years with ECOG performance status </= 2
- 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 found to be MRD-positive at time of screening
- Patients with plasma cell leukemia or other disorder of plasma cell neoplasm
- Patient who are receiving other therapy with the intent of treating myeloma with the exception of bisphosphonates
- Patients being treated for another, potentially life-limiting malignancy with 3-year lead-in to study enrollment, with the exception of non-melanoma skin cancer or in situ malignancy or malignancies that have received definitive curative therapy
- Prior organ transplant or condition requiring immunosuppressive therapy
- Prior allogeneic hematopoietic cell transplant
- Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or IV heart failure, uncontrolled coronary artery disease/arrhythmia, psychiatric or social disorder that would compromise compliance with the study schema
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions
This study will test whether stopping maintenance therapy in people with multiple myeloma in MRD-negative remission has the same effect on disease control as continuing this therapy. The study will look at whether people currently on maintenance therapy can safely stop this treatment and continue with active surveillance instead while keeping their MRD-negative remission status for at least 1 year.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Cessation of continuous matinenace therapy
- Keywords
- Plasma Cell Myeloma, MRD-Negative, MRD-Negative Remission, Memorial Sloan Kettering Cancer Center, 19-422
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation of continuous matinenace therapyOther
Cessation of maintenance therapy for participants in sustained MRD-negative remission while under careful observation
| Study group | Role | What they receive |
|---|---|---|
| MRD-Negative Participants | Not described Receives: Other: Cessation of continuous matinenace therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Maintaining a MRD-negative state for one year of enrolling on this study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start3 Jan 2020
- Primary completion3 Jan 2027 (estimated)
- Study completion3 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Korde, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221178
- Sponsor's protocol ID
- 19-422
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions
- ClinicalTrials.gov ID
- NCT04221178
- Acronym / sponsor ID
- 19-422
- Conditions
- Plasma Cell Myeloma
- Keywords
- Plasma Cell Myeloma, MRD-Negative, MRD-Negative Remission, Memorial Sloan Kettering Cancer Center, 19-422
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 3 Jan 2027 (estimated)
- First posted
- 9 Jan 2020 (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.
This study will test whether stopping maintenance therapy in people with multiple myeloma in MRD-negative remission has the same effect on disease control as continuing this therapy. The study will look at whether people currently on maintenance therapy can safely stop this treatment and continue with active surveillance instead while keeping their MRD-negative remission status for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD-Negative Participants | – | Other: Cessation of continuous matinenace therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted at MSKCC. Efforts will be made to ensure that women and minority groups are adequately represented in this trial. All patients will be seen by MSKCC myeloma physicians and associated MSKCC co-investigators, enrolled and registered at MSKCC.
Key inclusion criteria (4 listed)
- Patients with plasma cell myeloma treated with any number of prior lines of therapy, who at the time of study enrollment have had sustained MRD-negativity at a given timepoint and a subsequent time point with an interval of 3 or more years while on continuous maintenance therapy. MRD-negativity is defined per the International Myeloma Working Group Consensus Panel.
- MRD positivity will be defined by detection of 1 or more neoplastic plasma cells in 10^5 nucleated cells by flow cytometry as per IMWG criteria (i.e., sensitivity of 10-5)
- Age >/= 18 years with ECOG performance status </= 2
- 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 (7 listed)
- Patients found to be MRD-positive at time of screening
- Patients with plasma cell leukemia or other disorder of plasma cell neoplasm
- Patient who are receiving other therapy with the intent of treating myeloma with the exception of bisphosphonates
- Patients being treated for another, potentially life-limiting malignancy with 3-year lead-in to study enrollment, with the exception of non-melanoma skin cancer or in situ malignancy or malignancies that have received definitive curative therapy
- Prior organ transplant or condition requiring immunosuppressive therapy
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 |
|---|---|---|
| Cessation of continuous matinenace therapyCessation of maintenance therapy for participants in sustained MRD-negative remission while under careful observation | Other | MRD-Negative Participants |
Primary outcome
Progression Free Survival
Time frame: 1 year
Maintaining a MRD-negative state for one year of enrolling on this study
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 10 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Neha Korde, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 1 year). 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 10 Feb 2026.