About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
A prospective cohort study of approximately 544 patients receiving allogeneic HCT for multiple myeloma in CIBMTR centers in the US matched to a historical control patients treated with autoHCT between 2010 and 2016
Trial design
Cohort
Prospective
Treatments tested in this trial
Allogeneic Hematopoietic Stem Cell Transplant
Other interventionThis observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of matched autoHCT controls.
Treatment groups
Trial outcomes
Primary outcomes
Compare five-year survival
Compare five-year overall survival between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients
Secondary outcomes
Progression-free survival (PFS)
five-year PFS probabilities between the AlloHCT cohort and an age and disease risk matched cohort of autoHCT patients
Relapse or progression
Myeloma recurrence or progression will be defined per International Myeloma Working Group (IMWG) guidelines
Transplant related mortality
Death from any cause within 28 days after alloHCT or death in the absence of progression/relapse of MM after day 28 post transplant
Incidence of acute GVHD
Occurrence of Grade I, II and III/IV skin, gastrointestinal, or liver abnormalities fulfilling the Consensus criteria of Grades II-IV acute GVHD
Sponsors and contacts
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Center for International Blood and Marrow Transplant Research
Lead sponsor
National Marrow Donor Program
Collaborator