Bortezomib as First Salvage Therapy for Myeloma Patients Previously Exposed to Bortezomib as Initial Treatment. (REBOUND)
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|ClinicalTrials.gov Identifier: NCT02797041|
Recruitment Status : Unknown
Verified June 2016 by Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata.
Recruitment status was: Active, not recruiting
First Posted : June 13, 2016
Last Update Posted : June 14, 2016
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: Bortezomib|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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 Start Date :||August 2015|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||June 2016|
- Drug: Bortezomib
Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatmentOther Name: No other drugs evaluated
- Response rate [ Time Frame: March, 31, 2016 ]International Myeloma Study Group Criteria
- Adverse events [ Time Frame: March,31, 2016 ]Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)
- Progression free survival 1 and 2 [ Time Frame: March, 31, 2016 ]
- Time to next treatment [ Time Frame: March, 31, 2016 ]
- Overall survival [ Time Frame: March, 31, 2016 ]
- Secondary primary malignancies [ Time Frame: March, 31, 2016 ]Types and incidence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797041
|Principal Investigator:||Pellegrino Musto, MD||IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy|