Clinical trial NCT02797041: Bortezomib as First Salvage Therapy for Myeloma Patients Previously Exposed to Bortezomib as Initial Treatment.
Official title: REal Life, Retrospective Study of BOrtezomib Use as secoND Treatment for Myeloma Patients Previously Exposed to Bortezomib-based Therapies as First Line
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Bortezomib
Relapsed multiple myeloma
Rechallenge
Lead sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment and that after their first line treatment's relapse received again a bortezomib-based treatment

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.


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.

Primary outcomes:
measure: Response rate
timeFrame: March, 31, 2016
measure: Adverse events
timeFrame: March,31, 2016
Secondary outcomes:
measure: Progression free survival 1 and 2
timeFrame: March, 31, 2016
measure: Time to next treatment
timeFrame: March, 31, 2016
measure: Overall survival
timeFrame: March, 31, 2016
measure: Secondary primary malignancies
timeFrame: March, 31, 2016
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy
name: Pellegrino Musto, MD
role: PRINCIPAL_INVESTIGATOR
References: