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)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Medicare beneficiary

• Stage II or III multiple myeloma and/or primary plasma cell leukemia

• Eligible to receive an allogeneic HCT from any suitable allogeneic donor (as determined by the transplant center) including umbilical cord blood

• Will receive allogeneic HCT at a US transplant center

• Agree to submit comprehensive clinical data on their pre- and post-transplant clinical status and outcomes to the CIBMTR

Locations
United States
Minnesota
Center for International Blood and Marrow Transplant Research
RECRUITING
Minneapolis
Contact Information
Primary
Mona Patel
mopatel@mcw.edu
414-805-0655
Time Frame
Start Date: 2017-07-25
Estimated Completion Date: 2028-04
Participants
Target number of participants: 544
Treatments
Allogeneic HCT
Prospectively enrolled cohort of patients receiving allogeneic hematopoietic cell transplantation for multiple myeloma
Historical autoHCT
Historical cohort of patients with autologous hematopoietic cell transplantation between 2010 and 2016
Related Therapeutic Areas
Sponsors
Collaborators: National Marrow Donor Program
Leads: Center for International Blood and Marrow Transplant Research

This content was sourced from clinicaltrials.gov

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