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

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.

Conditions

Multiple Myeloma

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Illinois Cancer Center, Chicago, Illinois, United States, 60612

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Illinois at Chicago,

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

Study Record Dates

2029-01