Retrospective Survey of Re-treatment With Bortezomib

NCT01524445 | Completed

• 2 other identifiers: CR01817526866138MMY4053
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were treated again with bortezomib a second time after a treatment-free period of at least 6 months. During this non-interventional study (this means that no drug is being tested in this study) the safety and effectiveness (whether it works or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma. Only data already mentioned in your clinical file will be collected. About 100 adult patients will take part in the study

Conditions

Hematological Cancer; Multiple Myeloma

Keywords

Bortezomib; Velcade; multiple myeloma; retrospective study, response rate, medical resource utilization

Outcome Measures

Primary Outcomes (1)

• overall response after retreatment

  overall response after retreatment will be assessed from initial diagnosis to the time of data collection

  Day 1

Secondary Outcomes (6)

• number of medical care encounters

  Day 1

• duration of medical care encounters

  Day 1

• duration of hospitalization

  Day 1

• number and character of diagnostic and therapeutic tests and procedures

  Day 1

• outpatient medical encounters and treatments

  Day 1

Study Arms (1)

bortezomib retreatment

bortezomib retreatment due to relapse Patients who received bortezomib-containing chemotherapy as first-line treatment for MM experienced partial response or better and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months

Other: bortezomib retreatment due to relapse

Interventions

bortezomib retreatment due to relapse OTHER

Patients who received bortezomib-containing chemotherapy as first-line treatment for MM, experienced partial response or better, and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months

bortezomib retreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinic; Hospital

You may qualify if:

• Has a current diagnosis/was diagnosed with MM or secretory MM
• Was previously treated with bortezomib-containing chemotherapy
• Responded to bortezomib as first-line treatment
• Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease (following the first bortezomib treatment), after a treatment-free interruption of at least 6 months

You may not qualify if:

• Was a pregnant or breastfeeding woman while receiving either first-line or second-line treatment with Velcade
• Has received bortezomib-containing chemotherapy for the first time following a first relapse or later
• Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (4)

Unknown Facility

Alexandroupoli, Greece

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Athens Attica, Greece

Location

Unknown Facility

Pátrai, Greece

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: February 2, 2012
• Study Start: March 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

GR (4)