Actively Recruiting
Bortezomib-bendamustine-melphalan vs High-dose Melphalan in Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma - a Single Center Retrospective Cohort Study
Led by Uppsala University · Updated on 2024-11-29
100
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
U
Uppsala County Council, Sweden
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate and compare the effectiveness and safety of two conditioning regimens, bortezomib-bendamustine-melphalan (BBM) and high-dose melphalan (HDM), in patients with relapsed multiple myeloma undergoing autologous hematopoietic stem cell transplantation (ASCT). The study is a retrospective single center cohort analysis conducted at Uppsala University Hospital, reviewing treatments given from 2011 to 2018 and comparing them to periods before and after. Patients who received BBM or HDM conditioning as part of their second ASCT after relapse will be studied using data from electronic medical records and the Swedish Cancer Registry. The study compares time to next treatment (TNT) between the first and second ASCT for each patient and evaluates differences in efficacy and severe adverse events between the two conditioning regimens. Subgroup analyses include factors like prior treatment response, maintenance therapies, and high-risk genetic features. Participants' medical records will be systematically analyzed for outcomes such as time to next treatment, progression-free survival, overall survival, depth of response, treatment-related mortality, neutropenia duration, engraftment time, hospitalization length, and serious adverse events up to 100 days after the second ASCT. The study involves monitoring these outcomes retrospectively over periods ranging from days to years after transplantation.
CONDITIONS
Brief Title
Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of first relapse after previous autologous stem cell transplant for multiple myeloma according to the International Myeloma Working Group
- Treated with a second autologous stem cell transplant as part of second line treatment at Uppsala University Hospital
- Conditioning at second transplant with bortezomib-bendamustine-melphalan or high-dose melphalan only
You will not qualify if you...
- Double (tandem) autologous stem cell transplant in first or second line treatment
- Allogenic hematopoietic stem cell transplantation as part of first or second line therapy
- Missing key data such as dates of transplants, induction treatment start, medical records from hospitalization, follow-up visits, progression, or first treatment after second transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 50 days around the transplant period
Participants receive conditioning treatment with either bortezomib-bendamustine-melphalan or high-dose melphalan as part of their second autologous stem cell transplant for relapsed multiple myeloma.
Hospitalization and treatment visits during transplant period
Duration - Up to 18 years
Participants are monitored for safety and outcomes including severe adverse events, neutropenia, engraftment, hospitalization duration, and survival following their transplant.
Visits and assessments up to 100 days post-transplant and long-term follow-up visits
Trial Site Locations
Total: 1 location
1
Akademiska sjukhuset
Uppsala, Sweden
Actively Recruiting
Research Team
T
Thomas Silfverberg, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here