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

NCT05192122 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2021-1196
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy

  Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy (MRD defined as 10-6)

  12 months after stopping maintenance therapy

Secondary Outcomes (14)

• Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy

  2 years after stopping maintenance therapy

• Number of participants that relapse per IMWG at 1 year after stopping maintenance therapy

  1 year after stopping maintenance therapy

• Number of participants that relapse per IMWG at 2 years after stopping maintenance therapy

  2 years after stopping maintenance therapy

• Progression-free survival (PFS) in multiple myeloma patients

  I year

• Progression-free survival (PFS) in multiple myeloma patients

  2 years

Study Arms (2)

Bone marrow MRD-negative VGPR or CR

OTHER

Discontinue maintenance therapy after at least three years

Other: Discontinue maintenance therapy SOC

Bone marrow MRD-positive VGPR or CR

OTHER

Continue maintenance therapy as per SOC

Other: Discontinue maintenance therapy SOC

Interventions

Discontinue maintenance therapy SOC OTHER

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.

Bone marrow MRD-negative VGPR or CR; Bone marrow MRD-positive VGPR or CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome
• Prior organ transplant or condition requiring immunosuppressive therapy
• Prior allogeneic hematopoietic cell transplant
• Treatment with any investigational drug within 30 days prior to enrollment
• Unable to sign an informed consent or their legally authorized represnetative

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Karen Sweiss, PhamD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Sweiss, PharmD

CONTACT

312-996-0875; ksweis2@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with sustained MRD negativity (defined as MRD negative at 2 time points, at least 12 months apart) will stop maintenance therapy. Bone marrow MRD testing must be performed at UIC prior to study entry can be counted as the first time point as long as the patient has received at least 2 years of maintenance at the time of MRD testing. These patients will then be monitored for sustained MRD-negativity after stopping therapy.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 14, 2022
• Study Start: December 31, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)