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| ID | Type | Description | Link |
|---|---|---|---|
| SEANM | Registry Identifier | Baghdad Hematology Center Ethical committee |
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No patients were enrolled in the study
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| Name | Class |
|---|---|
| Baghdad Medical City | OTHER |
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Bortezomib considered the standard of care for treating multiple myeloma patients, the aim was to assess the safety and efficacy of newly approved drug (Alvocade ®) in Iraq, in newly diagnosed patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Therapy | Experimental | Bortezomib will be administered as part of VCD or VRD protocols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib 3.5 MG | Drug | VCD protocol
VRD protocol:
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment the safety of Alvocade® therapy | Monitoring the rate of any adverse effect/event that will occur during the induction therapy | During 6 months |
| Assessment the effecacy of Alvocade® therapy | Assessment of overall response rate (ORR) of treatment after completion of induction protocol | At end of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| First assessment response | Assessment of response rate after 2 cycle from starting treatment protocol | At end of 2 months |
| Second assessment response | Assessment of response rate after 4 cycle from starting treatment protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali M Jawad, PhD | University of Baghdad | Principal Investigator |
| Bassam F Matti, PhD | Baghdad Medical City | Principal Investigator |
| Tareq A Saleh, PhD | Baghdad Medical City | Study Chair |
| Mahammed S Abbas, PhD | Baghdad Medical City | Study Director |
| Mohammed K Al-Qayyim, PhD | Baghdad Medical City | Principal Investigator |
| Alaaldin S Naji, PhD | University of Baghdad | Principal Investigator |
| Ammer F Majid, PhD | Baghdad Medical City | Principal Investigator |
| Adil S Al-Oqaby, PhD | Baghdad Medical City | Principal Investigator |
| Mazin A Shubir, PhD | Baghdad Medical City | Principal Investigator |
| Hawraa D Jumaa, PhD | Baghdad Medical City |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baghdad Hematology center - Baghdad Medical City | Baghdad | Bab-Almuadham | 12221 | Iraq |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
|
| At end of 4 months |
| Third assessment response | Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle) | At end of 6 months |
| Principal Investigator |
| Hayder A Fawzi, PhD | Al-Rasheed University College | Principal Investigator |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |