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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02797041

Acronym

REBOUND

Enrollment

100

Registered

2016-06-13

Start date

2015-08-31

Completion date

2016-06-30

Last updated

2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple myeloma, Bortezomib, Relapsed multiple myeloma, Rechallenge

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.

Interventions

DRUGBortezomib

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Response rate	March, 31, 2016	International Myeloma Study Group Criteria
Adverse events	March,31, 2016	Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)

Secondary

Measure	Time frame	Description
Progression free survival 1 and 2	March, 31, 2016	—
Time to next treatment	March, 31, 2016	—
Overall survival	March, 31, 2016	—
Secondary primary malignancies	March, 31, 2016	Types and incidence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026