Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 26866138MMY4039 | Other Identifier | Janssen Korea, Ltd. | |
| BORKOR5021 | Other Identifier | Janssen Korea, Ltd. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug | bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | at the end of every 3 week cycle | |
| Overall response rate | 6-12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| An Observational, Prospective Analysis of Retreatment with Bortezomib for Multiple Myeloma | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |