RECRUITING

Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma

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

Multiple myeloma (MM) is the second most common hematologic malignancy in adults. The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). Allogeneic HCT (alloHCT) is the only potentially curative therapy available to patients with MM. However, the significant morbidity and mortality of this procedure historically limited its application in older patients. Thus, although potentially curative, standard risk MM patients have excellent prognoses in the era of novel therapies which reduces the overall benefit of alloHCT. However, because the outcomes for high-risk MM remain poor despite the best available standard therapies (overall survival of 24-36 months), initial data suggest that alloHCT should be explored in this subset.

Official Title

Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma: A Study to Develop Evidence of Effectiveness for the Centers for Medicare and Medicaid Services (CMS)

Quick Facts

Study Start:2017-07-25
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03127761

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Medicare beneficiary
  2. * Stage II or III multiple myeloma and/or primary plasma cell leukemia
  3. * Eligible to receive an allogeneic HCT from any suitable allogeneic donor (as determined by the transplant center) including umbilical cord blood
  4. * Will receive allogeneic HCT at a US transplant center
  5. * Agree to submit comprehensive clinical data on their pre- and post-transplant clinical status and outcomes to the CIBMTR
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mona Patel
CONTACT
414-805-0655
mopatel@mcw.edu

Principal Investigator

Anita D'Souza, MD, MS
STUDY_CHAIR
CIBMTR, Medical College of Wisconsin
Parameswaran Hari, MD, MS
STUDY_CHAIR
CIBMTR, Medical College of Wisconsin

Study Locations (Sites)

Center for International Blood and Marrow Transplant Research
Minneapolis, Minnesota, 55401
United States

Collaborators and Investigators

Sponsor: Center for International Blood and Marrow Transplant Research

  • Anita D'Souza, MD, MS, STUDY_CHAIR, CIBMTR, Medical College of Wisconsin
  • Parameswaran Hari, MD, MS, STUDY_CHAIR, CIBMTR, Medical College of Wisconsin

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 Date2017-07-25
Study Completion Date2028-04

Study Record Updates

Study Start Date2017-07-25
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma

Additional Relevant MeSH Terms

  • Multiple Myeloma