Comparing bortezomib-bendamustine-melphalan to melphalan for treating multiple myeloma
Bortezomib-bendamustine-melphalan vs High-dose Melphalan in Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma - a Single Center Retrospective Cohort Study
Uppsala University · NCT06245629
This study is testing if a new treatment combining bortezomib, bendamustine, and melphalan can help people with relapsed multiple myeloma do better than the standard high-dose melphalan treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University (other) |
| Drugs / interventions | daratumumab |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT06245629 on ClinicalTrials.gov |
What this trial studies
This project evaluates the efficacy and safety of a new conditioning regimen, bortezomib-bendamustine-melphalan (BBM), in combination with autologous hematopoietic stem cell transplantation (ASCT) for patients with relapsed multiple myeloma. The study is retrospective and compares outcomes from patients treated with BBM to those who received high-dose melphalan (HDM) in previous and subsequent periods. Data will be collected from electronic medical records and the Swedish Cancer Registry, focusing on treatment efficacy and adverse events. The study aims to provide insights into the effectiveness of BBM compared to the standard HDM regimen.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with relapsed multiple myeloma who are undergoing a second ASCT.
Not a fit: Patients who have undergone allogenic stem cell transplantation or those with double ASCTs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with relapsed multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar conditioning regimens, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of first relapse after previous ASCT for multiple myeloma according to the International Myeloma Working Group. * Treated with a second ASCT (ASCT2) as part of second line treatment at UUH. * Conditioning at ASCT2 with bortezomib-bendamustine-melphalan or high-dose melphalan only. Exclusion Criteria: * Double (tandem) ASCT in first or second line treatment * Allogenic haematopoietic stem cell transplantation as part of first or second line therapy * Failure to meet the minimal dataset, defined as: (date of ASCT1 and ASCT2, date of start of induction treatment for relapsed myeloma prior to ASCT2, medical records from hospitalization for ASCT2, at least one follow-up visit (unless early death before first follow-up visit), date of progression and first treatment of relapsed multiple myeloma after ASCT2.
Where this trial is running
Uppsala
- Akademiska sjukhuset — Uppsala, Sweden (RECRUITING)
Study contacts
- Principal investigator: Honar Cherif, MD, PhD — Uppsala University
- Study coordinator: Thomas Silfverberg, MD
- Email: thomas.silfverberg@regiondalarna.se
- Phone: +4623492000
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.
Conditions: Myeloma Multiple, Autologous hematopoietic stem cell transplantation, Melphalan, Bendamustine, Bortezomib