What this study is
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.
What's being tested
- Allogeneic Hematopoietic Stem Cell Transplant
Intervention · OTHER
This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of matched autoHCT controls.
Study details
- 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)
- Sponsor
- Center for International Blood and Marrow Transplant Research
- Conditions
- Multiple Myeloma
- Enrolling
- 544 people
- Starts
- 2017-07-25
- Est. completion
- 2028-04
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCenter for International Blood and Marrow Transplant Research
Minneapolis, Minnesota, United States
- Michael Tierney · ContactDatabaseIRB@NMDP.org
Recruiting
Study team
Sponsor
Center for International Blood and Marrow Transplant Research
Study ID 17-CMS-MM
Study chair
Anita D'Souza, MD, MS
CIBMTR, Medical College of Wisconsin
Study chair
Parameswaran Hari, MD, MS
CIBMTR, Medical College of Wisconsin
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.