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

Multiple Myeloma Clinical Trial

— REBOUND  

Official title:

REal Life, Retrospective Study of BOrtezomib Use as secoND Treatment for Myeloma Patients Previously Exposed to Bortezomib-based Therapies as First Line

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02797041
• Other study ID #: CentroROB
• Status: Active, not recruiting
• Phase: N/A
• First received: June 2, 2016
• Last updated: June 13, 2016
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: IRCCS Centro di Riferimento Oncologico della Basilicata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro di Riferimento Oncologico della Basilicata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	International Myeloma Study Group Criteria	March, 31, 2016	No
Primary	Adverse events	Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)	March,31, 2016	Yes
Secondary	Progression free survival 1 and 2		March, 31, 2016	No
Secondary	Time to next treatment		March, 31, 2016	No
Secondary	Overall survival		March, 31, 2016	No
Secondary	Secondary primary malignancies	Types and incidence	March, 31, 2016	Yes