A Retreatment Study With Bortezomib for Multiple Myeloma
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Purpose
The purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma |
- To monitor such factors as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, the concomitant drugs that are used for re-treatment and the pattern of treatment. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: at the end of every 3 week cycle ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
| Enrollment: | 56 |
| Study Start Date: | November 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
001
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
|
Drug: bortezomib
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
|
Detailed Description:
It will be essential to obtain the Korean clinical data about the efficacy and safety of the re-treatment with bortezomib as well as to analyze its actual pattern. The current trial is a prospective, multi-center, Phase 4, observational study that will be conducted to collect such demographic data as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, the concomitant drugs that are used for re-treatment and the pattern of treatment for patients with multiple myeloma and who were re-treated with injectable bortezomib. Also safety data will be collected. Observational Study -No investigational drug administered
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Among patients who are scheduled to be re-treated with bortezomib for the recurrence of multiple myeloma and who have submitted a written informed consent to provide their personal data in relation to their former, prescribed use of bortezomib for the treatment of multiple myeloma in Korea.
Inclusion Criteria:
- Patients with multiple myeloma
- Patients who were treated with bortezomib monotherapy or bortezomib combination therapy
- Patients who relapsed after >= six months interval since last dose of bortezomib
- Patients who had a treatment response of higher than partial remission (PR) to the previous bortezomib therapy
- Patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial
Exclusion Criteria:
- The current presence of or a past history of hypersensitivity to bortezomib or its constituents
- Severe hepatic dysfunction (AST or ALT at first use>= x 5 upper normal)
- Pregnant women
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01030302 History of Changes |
| Other Study ID Numbers: | CR015814, 26866138MMY4039, BORKOR5021 |
| Study First Received: | October 29, 2009 |
| Last Updated: | March 7, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Bortezomib retreatment Velcade Proteasome inhibitor Bortezomib |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013