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

Multiple Myeloma Clinical Trial

— HEME-20  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192122
• Other study ID #: 2021-1196
• Status: Recruiting
• Phase: Phase 1
• Start date: December 31, 2021
• Est. completion date: January 2029

Study information

• Verified date: November 2023
• Source: University of Illinois at Chicago
• Contact: Karen Sweiss, PharmD
• Phone: 312-996-0875
• Email: ksweis2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is 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 Multiple Myeloma (MM) patients. Patients will be eligible if they have a diagnosis of active MM, have completed at least 2 years of maintenance therapy post-ASCT, and meet International Myeloma Working Group (IMWG) criteria for very good partial response (VGPR) or complete response (CR). Once eligibility is confirmed and informed consent is signed, MRD testing will be performed on routine bone marrow aspirate using standard of care next-generation sequencing (NGS) testing and will be defined at a threshold of 10-6. Patients who are in VGPR or CR and sustained MRD (defined as MRD-negative at two time points that are at least 1 year apart) will go on to discontinue maintenance therapy. MRD-positive patients will continue to be treated as per standard of care (i.e., continue maintenance). Both MRD-positive and MRD-negative patients will be followed as per standard of care for progression using IMWG criteria and for MRD. Quality of life will be assessed at baseline and at 3 months after discontinuing maintenance therapy in MRD-negative patients and at baseline and at the time of next follow-up after MRD testing in MRD-positive patients. In patients who stop maintenance therapy, MRD status will be re-assessed by yearly bone marrow aspirate as per standard of care. Treatment for relapsed/ refractory myeloma will be instituted at the treating physician's discretion for documented clinical and/or biochemical progression. For all patients, a 5-mL peripheral blood and bone marrow sample will be collected and stored at the time of each standard of care bone marrow biopsy and at time of documented disease progression for correlative testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasm, Residual
• Neoplasms, Plasma Cell

Intervention

Other:
• Discontinue maintenance therapy SOC
Continue maintenance therapy SOC

Locations

Country	Name	City	State
United States	University of Illinois Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	2 years after stopping maintenance therapy
Secondary	Number of participants that relapse per IMWG at 1 year after stopping maintenance therapy	Number of participants that relapse per IMWG	1 year after stopping maintenance therapy
Secondary	Number of participants that relapse per IMWG at 2 years after stopping maintenance therapy	Number of participants that relapse per IMWG	2 years after stopping maintenance therapy
Secondary	Progression-free survival (PFS) in multiple myeloma patients	PFS in multiple myeloma patients at 1 year	I year
Secondary	Progression-free survival (PFS) in multiple myeloma patients	PFS in multiple myeloma patients at 2 years	2 years
Secondary	Progression-free survival (PFS) in multiple myeloma patients	PFS in multiple myeloma patients at 3 years	3 years
Secondary	Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy	Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy therapy using the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma questionnaire (EORTC QLQ-MY20) questionnaire	Baseline
Secondary	Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy	Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy using the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma questionnaire (EORTC QLQ-MY20) questionnaire	3 months
Secondary	Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response	Measuring the disease response	1 year
Secondary	Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response	Measuring the disease response	2 years
Secondary	Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response	Measuring the disease response	3 years
Secondary	Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response	PFS in multiple myeloma patients at 1 year	1 year
Secondary	Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response	PFS in multiple myeloma patients at 2 years	2 years
Secondary	Correlate peripheral blood circulating myeloma cell numbers (CELLSEARCH) with conventional IMWG response	PFS in multiple myeloma patients at 3 years	3 years