Recruiting
Phase 1

Free from Maintenance Drug Therapy

Sponsor:

University of Illinois at Chicago

Code:

NCT05192122

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Discontinue maintenance therapy SOC

Study Details

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

Study ID

NCT05192122

Start date

Dec 31, 2021

Status verified date

Dec, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Discontinue 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.

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 and Locations

Central contacts

Karen Sweiss, PharmD

312-996-0875ksweis2@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Karen Sweiss, PharmD

312-996-0875ksweis2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-12-18.