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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)


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.Multiple myeloma (MM) is the second most common hematologic malignancy in adults. Overall survival (OS) in MM has improved significantly in the last 15 years with the emergence of novel therapies

Trial Eligibility

Inclusion Criteria: * 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

Study Info

Organization

Center for International Blood and Marrow Transplant Research


Primary Outcome

Compare five-year survival


Outcome Timeframe 5 years post transplant

NCTID NCT03127761

Start Date 2017-07-25

Completion Date 2027-05

Enrollment Target 544

Interventions

OTHER Allogeneic Hematopoietic Stem Cell Transplant

Locations Recruiting

Center for International Blood and Marrow Transplant Research

United States, Minnesota, Minneapolis


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