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

June 13, 2016 updated by: Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro di Riferimento Oncologico della Basilicata

Investigators

  • Principal Investigator: Pellegrino Musto, MD, IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (ESTIMATE)

June 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CentroROB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Central database of single patients

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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