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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04221178

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

7.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Plasma Cell Myeloma	Other: Cessation of continuous matinenace therapy

Study Design

Study Type:

Observational

Anticipated 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 :

Jan 3, 2020

Anticipated Primary Completion Date :

Jan 3, 2024

Anticipated Study Completion Date :

Jan 3, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Progression Free Survival [1 year]
Maintaining a MRD-negative state for one year of enrolling on this study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553