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Stopping Maintenance Therapy in People With Multiple Myeloma in MRD-Negative Remission

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 2, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment
Plasma Cell Myeloma Other: Cessation of continuous matinenace therapy

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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, 2022
Estimated Study Completion Date : January 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
    Maintaining a MRD-negative state for one year of enrolling on this study



Information from the National Library of Medicine

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.


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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
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: C Ola Landgren, MD, PhD 1212-639-5126 landgrec@mskcc.org
Contact: Neha Korde, MD 1212-639-7664 korden@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Ola Landgren, MD    212-639-5126      
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Ola Landgren, MD    212-639-5126      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Ola Landgren, MD, PhD    212-639-5126      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Ola Landgren, MD, PhD    212-639-5126      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: C. Ola Landgren, MD, PhD    212-639-5126      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: C Ola Landgren, MD, PhD    212-639-5126      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Ola Landgren, MD, PhD    212-639-5126      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: C Ola Landgren, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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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 2, 2020
Last Verified: February 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Plasma Cell Myeloma
MRD-Negative
MRD-Negative Remission
Memorial Sloan Kettering Cancer Center
19-422
Additional relevant MeSH terms:
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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