Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment bortezomib
Target proteasome
Sponsor IRCCS Centro di Riferimento Oncologico della Basilicata
Start date August 2015
End date March 2016
Trial size 100 participants
Trial identifier NCT02797041, CentroROB

Summary

This observational, non-interventional, retrospective, multicenter, national study focuses on collecting information about the effectiveness and safety of bortezomib re-use at first relapse in MM patients already treated in their first line with a bortezomib-based regimen, re-challenged with the same drug according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations.

Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in Italy. Approximately, data of up to 100 patients will be collected.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Primary Outcomes

Measure
Response rate
time frame: March, 31, 2016
Adverse events
time frame: March,31, 2016

Secondary Outcomes

Measure
Progression free survival 1 and 2
time frame: March, 31, 2016
Time to next treatment
time frame: March, 31, 2016
Overall survival
time frame: March, 31, 2016
Secondary primary malignancies
time frame: March, 31, 2016

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients satisfying all of the following criteria will be enclosed in the study: - Age ≥ 18 years old - Patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment (both in clinical practice or clinical trials) even if followed by ASCT and that after their first line treatment's clinical or biochemical relapse received again a bortezomib-based treatment according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations. - Signed Informed Consent form if feasible Exclusion Criteria: - Patients not treated with bortezomib as first line therapy and/or second line therapy - Patients with more than one relapse before bortezomib re-use - Patients unable to understand and sign Informed Consent form (see exceptions listed in section 8 "Informed consent") - Patients who received bortezomib at relapse in combination with any investigational drug not-approved.

Additional Information

Official title REal Life, Retrospective Study of BOrtezomib Use as secoND Treatment for Myeloma Patients Previously Exposed to Bortezomib-based Therapies as First Line
Principal investigator Pellegrino Musto, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by IRCCS Centro di Riferimento Oncologico della Basilicata.