Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma

NCT06245629 | Recruiting FDA Drug

• 1 other identifier: 2023-04134-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate the efficacy and safety of the conditioning regimen bortezomib-bendamustine-melphalan (BBM) in combination with autologous hematopoietic stem cell transplantation (ASCT) in relapsed multiple myeloma given from 2011 to 2018 at Uppsala University Hospital. This approach will be retrospectively compared to high dose melphalan (HDM) in the same setting in the years prior to, and following the BBM-period. Data on efficacy and safety data will be collected through systematic analysis of electronic medical records and from the Swedish Cancer Registry.

Conditions

Myeloma Multiple

Keywords

Autologous hematopoietic stem cell transplantation; Melphalan; Bendamustine; Bortezomib

Outcome Measures

Primary Outcomes (1)

• Mean difference in time to next treatment (TNT) after ASCT1 and ASCT2 for each individual patient

  Average time to next myeloma treatment within each individual patient making each patient as its' own control

  0.2-18 years

Secondary Outcomes (9)

• Median time to next treatment after ASCT2

  0-18 years

• Median progression free survival (PFS) after ASCT2

  0-18 years

• Median overall survival after ASCT2

  0-18 years

• Depth of best response after ASCT2

  0-24 months

• Treatment related mortality

  0-12 months

Study Arms (2)

Bortezomib-bendamustine-melphalan

Myeloma patients receiving bortezomib-bendamustine-melphalan at autologous hematopoietic stem cell transplantation first relapse.

Drug: Bortezomib-bendamustine-melphalan

high-dose melphalan

Myeloma patients receiving high-dose melphalan at autologous hematopoietic stem cell transplantation at first relapse.

Interventions

Bortezomib-bendamustine-melphalan DRUG

The aim of this retrospective cohort study is to evaluate the efficacy and safety of the conditioning regimen BBM compared to HDM in the setting of relapsed multiple myeloma.

Also known as: High-dose melphalan

Bortezomib-bendamustine-melphalan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty consecutive patients, who were referred to UUH for a second ASCT after relapse in multiple myeloma following HDM and ASCT between 1 Nov 2011 and 30 Jun 2018 and who received conditioning with bortezomib-bendamustine-melphalan will be included in this study. As a control group, 25 consecutive patients who were treated with HDM prior to 1 Nov 2011 and 25 consecutive patients following 30 Jun 2018. The patients will be identified through the local European Society for Blood and Marrow Transplantation (EBMT) registry at UUH.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala County Council, Sweden: collaborator
• Dalarna County Council, Sweden: collaborator

Study Sites (1)

Akademiska sjukhuset

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Honar Cherif, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Silfverberg, MD

CONTACT

+4623492000; thomas.silfverberg@regiondalarna.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: February 7, 2024
• Study Start: November 24, 2024
• Primary Completion: March 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from 9 months after published article until 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal. To gain access, data requestors will need to sign a data access agreement.

Locations

SE (1)