Stopping Maintenance Therapy in People With Multiple Myeloma in MRD-Negative Remission
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04221178 |
Recruitment Status :
Recruiting
First Posted : January 9, 2020
Last Update Posted : March 31, 2022
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Condition or disease | Intervention/treatment |
---|---|
Plasma Cell Myeloma | Other: Cessation of continuous matinenace therapy |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions |
Actual Study Start Date : | January 3, 2020 |
Estimated Primary Completion Date : | January 3, 2024 |
Estimated Study Completion Date : | January 3, 2024 |

Group/Cohort | Intervention/treatment |
---|---|
MRD-Negative Participants |
Other: Cessation of continuous matinenace therapy
Cessation of maintenance therapy for participants in sustained MRD-negative remission while under careful observation |
- Progression Free Survival [ Time Frame: 1 year ]Maintaining a MRD-negative state for one year of enrolling on this study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221178
Contact: Neha Korde, MD | 212-639-7664 | korden@mskcc.org | |
Contact: Alexander Lesokhin, MD | 212-639-3069 | lesokhia@mskcc.org |
United States, New Jersey | |
Memoral Sloan Kettering Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Neha Korde, MD 212-639-7664 | |
Memoral Sloan Kettering Monmouth | Recruiting |
Middletown, New Jersey, United States, 07748 | |
Contact: Neha Korde, MD 212-639-7664 | |
Memorial Sloan Kettering Bergen | Recruiting |
Montvale, New Jersey, United States, 07645 | |
Contact: Neha Korde, MD 212-639-7664 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center @ Suffolk | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Neha Korde, MD 212-639-7664 | |
Memorial Sloan Kettering Westchester | Recruiting |
Harrison, New York, United States, 10604 | |
Contact: Neha Korde, MD 212-639-7664 | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Neha Korde, MD 212-639-7664 | |
Memorial Sloan Kettering Nassau | Recruiting |
Uniondale, New York, United States, 11553 | |
Contact: Neha Korde, MD 212-639-7664 |
Principal Investigator: | Neha Korde, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT04221178 |
Other Study ID Numbers: |
19-422 |
First Posted: | January 9, 2020 Key Record Dates |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Plasma Cell Myeloma MRD-Negative MRD-Negative Remission Memorial Sloan Kettering Cancer Center 19-422 |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |