Exploring Allogeneic Stem Cell Transplant for Older Patients with Multiple Myeloma
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)
This study is testing whether a stem cell transplant can help older patients with multiple myeloma, especially those with high-risk disease, to see how well it works compared to regular treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 544 (estimated) |
| Sex | All |
| Sponsor | Center for International Blood and Marrow Transplant Research Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT03127761 on ClinicalTrials.gov |
What this trial studies
This study assesses the outcomes of allogeneic hematopoietic cell transplantation (alloHCT) in Medicare beneficiaries diagnosed with multiple myeloma, particularly focusing on those with high-risk disease. It aims to gather comprehensive clinical data on patients who are eligible for alloHCT and will receive the procedure at designated transplant centers in the U.S. The study will analyze pre- and post-transplant clinical status and outcomes to better understand the potential benefits and risks associated with this treatment option in older patients. By leveraging data from the Center for International Blood and Marrow Research, the study seeks to provide insights into the efficacy of alloHCT compared to standard therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicare beneficiaries with stage II or III multiple myeloma or primary plasma cell leukemia who are eligible for alloHCT.
Not a fit: Patients with early-stage multiple myeloma or those not eligible for alloHCT may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of alloHCT as a potentially curative treatment for high-risk multiple myeloma patients.
How similar studies have performed: While alloHCT has been explored in various contexts, this specific focus on older Medicare beneficiaries with high-risk multiple myeloma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- Center for International Blood and Marrow Transplant Research — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Mona Patel
- Email: mopatel@mcw.edu
- Phone: 414-805-0655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.