Retrospective Survey of Re-treatment With Bortezomib

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT01524445
First received: June 16, 2011
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Hematological Cancer
Multiple Myeloma
Other: bortezomib retreatment due to relapse
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • overall response after retreatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    overall response after retreatment will be assessed from initial diagnosis to the time of data collection


Secondary Outcome Measures:
  • number of medical care encounters [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection

  • duration of medical care encounters [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection

  • duration of hospitalization [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection

  • number and character of diagnostic and therapeutic tests and procedures [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection

  • outpatient medical encounters and treatments [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection

  • safety and tolerability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    safety and tolerability will be evaluated based on the collection of serious and non serious adverse drug reactions from initial diagnosis to the time of data collection


Enrollment: 35
Study Start Date: March 2011
Study Completion Date: October 2011
Groups/Cohorts Assigned Interventions
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
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

Detailed Description:

This is an international, multicenter, non-interventional, retrospective study to evaluate the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma (MM) who responded to bortezomib as first-line treatment, experienced partial response or better, presented with relapsed disease, and were re-treated (second-line) with bortezomib (for at least 3 cycles) after a treatment-free interruption of at least 6 months. As this is a non-interventional study, no changes to the current treatment that the patient receives will be required, and no additional treatment will be provided by the company. The decision of the patients to take part in this study will not have any impact on the care they receive. All the appropriate treatment-related decisions will have been made by the treating physician(s), and only data available from clinical practice will be collected. Retrospective data will be collected at a single time point for each patient (the data collection visit). Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria. After receiving the signed informed consent form (ICF) from the patient (if required by local regulations), the investigator will start documenting the retrospective data for each patient using electronic data capture (eDC). After confirmation of the patient's eligibility, the patient's last visit, patient characteristics, predefined risk factors (if available), MM-related data, and first- and second-line bortezomib-related data will be documented in the Case Report Form (CRF). The patient's status after re-treatment with bortezomib, medical resource utilization data, as well as (serious) adverse drug reactions ([S]ADRs) will be collected. No blood, urine, or other biological samples will be taken, and no additional investigations will be performed. the current therapy of the patient will be maintained with no changes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinic; Hospital

Criteria

Inclusion Criteria:

  • 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
  • Completed bortezomib re-treatment at least 2 months ago Exclusion Criteria:
  • 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 participated in a clinical trial in which bortezomib was used as second-line treatment following a relapse after response to Velcade as first-line chemotherapy, and the study data are not publicly available at the time of inclusion in the current study
  • Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524445

Locations
Greece
Alexandroupoli, Greece
Athens, Greece
Athens Attica, Greece
Patra, Greece
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided

Responsible Party: EMEA Medical Affairs Director Oncology, Janssen-Cilag G.m.b.H, Germany
ClinicalTrials.gov Identifier: NCT01524445     History of Changes
Other Study ID Numbers: CR018175, 26866138MMY4053
Study First Received: June 16, 2011
Last Updated: June 11, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Bortezomib
Velcade
multiple myeloma
retrospective study, response rate, medical resource utilization

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014