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

NCT ID: NCT02797041

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-06-30

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Bortezomib

Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatment

Intervention Type: DRUG

Other Intervention Names

No other drugs evaluated

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro di Riferimento Oncologico della Basilicata

OTHER

Sponsor Role: lead

Responsible Party

Pellegrino Musto

Scientific Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pellegrino Musto, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy

Other Identifiers

CentroROB

Identifier Type: -

Identifier Source: org_study_id