Comparing bortezomib-bendamustine-melphalan to melphalan for treating multiple myeloma
Official title: Bortezomib-bendamustine-melphalan vs High-dose Melphalan in Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma - a Single Center Retrospective Cohort Study
Run by Uppsala University · NCT06245629 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Uppsala University Academic / other |
| Drugs / interventions | daratumumab |
| Locations | 1 site (Uppsala) |
| Status | Recruiting |
| Started | November 24, 2024 |
| Main results expected | March 31, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | November 29, 2024 |
| Trial ID | NCT06245629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with relapsed multiple myeloma who are undergoing a second ASCT.
✕Probably not a fit
Patients who have undergone allogenic stem cell transplantation or those with double ASCTs will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar conditioning regimens, but this specific comparison is novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BCD-248 plus daratumumab in relapsed or refractory multiple myeloma
This study tests whether adding BCD-248 to daratumumab helps people with relapsed or refractory multiple myeloma who have had prior lines of therapy.
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Immune Fitness in Older Adults with Relapsed or Refractory Multiple Myeloma
This study checks whether immune health before treatment can predict how well older adults with relapsed or refractory multiple myeloma respond to CAR-T or bispecific antibody therapies.
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Infectious complications in blood cancer patients treated with bispecific antibodies
This study tests how often infections occur in adults with blood cancers who are being treated with bispecific antibodies.
-
Mapping individual multiple myeloma biology to understand relapse and treatment resistance
This project will test whether combining clinical records with whole-genome and RNA sequencing plus blood tumor markers in people with multiple myeloma can reveal features that explain relapse and treatment resistance.
-
Multi-omics testing for blood and bone marrow cancers
This project will test a multi-omics lab approach on bone marrow, blood, biopsy and other fluid samples from people with suspected or known hematologic cancers to see if it can better characterize their disease.
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Anonymizing and combining past clinical, genetic, and imaging data from people with multiple myeloma to build AI prediction models.
This project will try to use already-collected clinical, genetic, and imaging data from adults with multiple myeloma to build AI models that predict disease progression and treatment response, with no new visits or tests required.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.