Novel Drugs After Allo-HSCT in Patients With Multiple Myeloma

NCT04506320 | Completed

• 1 other identifier: GITMO-NEW_ALLO_MM
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 2

Brief Summary

This is a retrospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian on patients submitted to allo-HSCT among Italian Transplant Centers GITMO. This study will evaluate all consecutive adult patients who received novel drugs after hematopoietic stem cell transplantation from related and unrelated donors between January 1, 2009 to December 31, 2018 in GITMO-affiliated Centers. This study will evaluate approximately 300 subjects (with competitive enrolment) from GITMO investigational centers.

Conditions

Multiple Myeloma; Stem Cell Transplant

Keywords

Allogeneic haematopoietic stem cell transplantation; Multiple Myeloma; Immuno-modulating agents; Protesome inhibitors; Monoclonal antibodies

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis

  these outcome measures will be assessed at 2 year from transplant

Secondary Outcomes (5)

• Progression Free Survival 1 (PFS1)

  these outcome measures will be assessed at 2 year from transplant

• Progression Free Survival 2 (PFS2)

  These outcome measures will be assessed at 2 year from transplant

• Acute Graft-versus-Host Disease (aGVHD)

  These outcome measures will be assessed at 100 days from transplant

• Chronic Graft-versus-Host Disease (cGVHD)

  These outcome measures will be assessed at 2 year from transplant

• Non-Relapse Mortality (NRM)

  These outcome measures will be assessed at 2 year from transplantation

Study Arms (1)

Patients with Multiple myeloma

Adult with diagnosis of multiple myeloma treated with Allo-HSCT from related - HLA identical or volunteer unrelated donor or haploidentical related donor performed from January 1, 2009 to december 31, 2018

Eligibility Criteria

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

Study Population

Patients with Multiple Myeloma who had received novel drugs after allogeneic transplantation (allo-HSCT) from related and unrelated donor between January 1, 2009 to December 31, 2018. Each enrolled patient will have a two-year of follow-up from the allogeneic transplant date

Sponsors & Collaborators

• Gruppo Italiano Trapianto di Midollo Osseo: lead
• Azienda Ospedaliero-Universitaria Careggi: collaborator

Study Sites (2)

Azienda Ospedaliera di Careggi

Florence, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Chiara Nozzoli

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 10, 2020
• Study Start: December 17, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)