RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2021-12-31

Study Completion:2029-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05192122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Karen Sweiss, PharmD

CONTACT

312-996-0875

ksweis2@uic.edu

Principal Investigator

Karen Sweiss, PhamD

PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Study Locations (Sites)

University of Illinois Cancer Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Karen Sweiss, PhamD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-31

Study Completion Date2029-01

Study Record Updates

Study Start Date2021-12-31

Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

Multiple Myeloma