An observational study in Multiple Myeloma, sponsored by Center for International Blood and Marrow Transplant Research. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Center for International Blood and Marrow Transplant Research · Observational
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 such as thalidomide, bortezomib and lenalidomide. The median life expectancy of patients with MM treated in the current era is more than 6 years, while SEER data from a slightly earlier time period (2008-12) estimated the 5 year survival at 48.5%. However, prognosis is not uniform and varies considerably based on a presenting features and response to therapy.
The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). There is controversy regarding the timing of autoHCT after initial novel therapy induction with randomized trials showing similar OS whether done early or delayed to time of relapse as salvage therapy. However, more recent trials comparing early versus delayed transplant support the benefit of early upfront 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. Current data from the Center for International Blood and Marrow Research (CIBMTR) show transplant-related mortality rates of 23 (20-26)% at 5 years with myeloablative conditioning.
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.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's planned enrollment of 544 is above the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Center for International Blood and Marrow Transplant Research is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
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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
Inclusion Criteria:
Prospectively enrolled cohort of patients receiving allogeneic hematopoietic cell transplantation for multiple myeloma
Other: Allogeneic Hematopoietic Stem Cell Transplant
Historical cohort of patients with autologous hematopoietic cell transplantation between 2010 and 2016
This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of matched autoHCT controls.
Compare five-year survival
Compare five-year overall survival between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients
Time frame: 5 years post transplant
Progression-free survival (PFS)
five-year PFS probabilities between the AlloHCT cohort and an age and disease risk matched cohort of autoHCT patients
Time frame: 5 years post transplant
Relapse or progression
Myeloma recurrence or progression will be defined per International Myeloma Working Group (IMWG) guidelines
Time frame: 5 years post transplant
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
Time frame: 5 years 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
Time frame: 5 years post transplant
Incidence of chronic GVHD
Occurrence of symptoms in any organ system fulfilling the criteria of chronic GVHD
Time frame: 5 years post transplant
Plan to share: Undecided
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Center for International Blood and Marrow Transplant Research