Bortezomib as First Salvage Therapy for Myeloma Patients Previously Exposed to Bortezomib as Initial Treatment. (REBOUND)

IRCCS Centro di Riferimento Oncologico della Basilicata

Status: Unknown

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib

Study type: Observational

Funder types: Other

Identifiers

NCT02797041

CentroROB

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (Autologous stem cell transplantation) 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 Societies of Hematology (SIE), Experimental Hematology (SIES) and Transplantation (GITMO), International Myeloma Working group (IMWG) and/or National Cancer Comprehensive Cancer Network (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.