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

Recruiting at 8 trial locations

Overseen By Neha Korde, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Neha Korde, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility 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

Treatment Details

Interventions

• Cessation of continuous maintenance therapy

Participant Groups

Group I: MRD-Negative Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+