RecruitingPhase 1NCT05192122

Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD

Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial): A Pilot Study of Minimal Residual Disease (MRD)-Driven Discontinuation of Maintenance (HEME-20)

Sponsor

University of Illinois at Chicago

Enrollment

50 participants

Start Date

Dec 31, 2021

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

A pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative MM patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial — called FREEDMM — is studying whether it is safe to stop maintenance drug therapy in multiple myeloma patients who have been in remission for at least 2 years after a stem cell transplant and show no detectable signs of disease remaining (called "minimal residual disease negative"). **You may be eligible if...** - You have multiple myeloma and received a stem cell transplant (autologous) - You have been on maintenance therapy for at least 2 years after the transplant - Your disease is in very good partial response (VGPR) or complete remission at the time of enrollment - You are in good general health (ECOG ≤ 2) **You may NOT be eligible if...** - You have plasma cell leukemia, AL amyloidosis, or POEMS syndrome - You have had a prior organ transplant or allogeneic (donor) stem cell transplant - You are currently on an investigational drug - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiscontinue maintenance therapy SOC

MRD testing through NGS Clonoseq will be performed as standard of care on all bone marrow samples. MRD negativity will be defined as observation of no templates at a sensitivity of 1 in a 1,000,000 (10-6) cells assessed, with a minimum of 1 million cells undergoing assessment. In addition, patients must be in VGPR/CR/PR as defined previously.