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This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of AlvocadeĀ® use in Iranian patients with multiple myeloma. No control groups were considered in the study design. The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of AlvocadeĀ® use in Iranian patients with multiple myeloma. Data were gathered in two booklets, containing information on sixteen injections, which were filled by the designated physician.
Exposure to AlvocadeĀ® in this study was defined as administration of bortezomib (AlvocadeĀ®, NanoAlvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16 injections).
The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
This study was single arm and the sample size of this study was 59 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoAlvand Bortezomib | 1.3 mg/m2 Bortezomib, IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | AlvocadeĀ® was given with a dose of 1.3 mg/m2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Safety assessment, including the incidence of AEs. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Assessment | Response categories (Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR), and stringent Complete Response (sCR)) were defined and reported based on the uniform response criteria of the International Myeloma Working Group. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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A population of 57 Iranian patients diagnosed with multiple myeloma under chemotherapy regimens with AlvocadeĀ® (with a dose of 1.3 mg/m2), were enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mani Ramzi, Prof. | Shiraz University of Medical Sciences, Shiraz, Iran | Principal Investigator |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| 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 |