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Taking people in United StatesPhase 1

Stopping Maintenance Treatment in Myeloma Based on Minimal Residual Disease

Tests stopping maintenance treatment in adults with multiple myeloma who show no minimal residual disease.

Plain-language title generated from the registry record
Registry title: Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD

Key facts

Where
Chicago, United StatesSee the site
Phase
Phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma who have had at least 2 years of maintenance treatment after a stem cell transplant and are in very good partial or complete response.

Age
18 years or older
Sex
All sexes can join
Disease stage
Multiple myeloma by IMWG definition, R-ISS stage I, 2 or 3, in VGPR or CR at enrolment
Earlier treatment
Own stem cell transplant (ASCT) followed by at least 2 years of maintenance therapy, such as lenalidomide or bortezomib
Biomarker or test result
Bone marrow MRD result (negative or positive) decides the group

Main reasons for not taking part

  • Plasma cell leukemia, AL amyloidosis or POEMS syndrome
  • Earlier organ transplant or a condition needing immunosuppressive therapy
  • Earlier donor stem cell (allogeneic) transplant
  • Any investigational drug within 30 days before enrolment
  • Unable to sign informed consent

Read by machine on 9 November 2026.

Where in United States

  • University of Illinois Cancer CenterChicago, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Illinois Chicago
Trial code
NCT05192122
Record updated
18 December 2025
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: ECOG Performance Status equal to or less than 2 within 30 days prior to registration; Revised International Staging System (R-ISS) I,2 or 3; Patients with multiple myeloma as defined by IMWG; Received at least 2 years of post ASCT maintenance (patients may have received any number of prior lines of therapy); Maintenance therapy is defined as any anti-myeloma therapy initiated after ASCT to prevent disease recurrence and prolong time in remission (i.e., lenalidomide, bortezomib, RVD, etc.); Disease response is VGPR or CR at the time of enrollment as defined by IMWG criteria; Patients or their legally authorized representative 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: Prior organ transplant or condition requiring immunosuppressive therapy; Prior allogeneic hematopoietic cell transplant; Treatment with any investigational drug within 30 days prior to enrollment; Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome; Unable to sign an informed consent or their legally authorized represnetative.

ClinicalTrials.gov NCT05192122