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

Plasma Cell Myeloma Clinical Trial

Official title:

A Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04221178
• Other study ID #: 19-422
• Status: Recruiting
• Start date: January 3, 2020
• Est. completion date: January 3, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Neha Korde, MD
• Phone: 212-639-7664
• Email: korden[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 3, 2025
• Est. primary completion date: January 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Other:
• Cessation of continuous matinenace therapy
Cessation of maintenance therapy for participants in sustained MRD-negative remission while under careful observation

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Maintaining a MRD-negative state for one year of enrolling on this study	1 year

External Links

•   Memorial Sloan Kettering Cancer Center