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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05192122
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 31, 2021
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Bone marrow MRD-negative VGPR or CR
    Discontinue maintenance therapy after at least three years
  • Other: Bone marrow MRD-positive VGPR or CR
    Continue maintenance therapy as per SOC

Primary Outcome Measure

Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy [ Time Frame: 12 months after stopping maintenance therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612
Karen Sweiss, PharmD
[email protected]
312-996-0875

Find similar trials in Chicago, IL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Illinois Cancer Center· Chicago, IL

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