Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients
NCT ID: NCT04348006
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2020-03-01
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Induction Therapy
Bortezomib will be administered as part of VCD or VRD protocols
Bortezomib 3.5 MG
VCD protocol
* V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC)
* C, Cyclophosphamide: 300 mg/m2 IV over 30 min (day 1, 8, 15)
* D, Dexamethasone oral: 40mg (days 1 to 4)
VRD protocol:
* V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC)
* R, Lenalid® cap 25 mg po (day 1 to 21)
* D, Dexamethasone oral: 40mg (days 1 to 4)
Interventions
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Bortezomib 3.5 MG
VCD protocol
* V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC)
* C, Cyclophosphamide: 300 mg/m2 IV over 30 min (day 1, 8, 15)
* D, Dexamethasone oral: 40mg (days 1 to 4)
VRD protocol:
* V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC)
* R, Lenalid® cap 25 mg po (day 1 to 21)
* D, Dexamethasone oral: 40mg (days 1 to 4)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age above 18 years old
Exclusion Criteria
* Smoldering MM
18 Years
80 Years
ALL
No
Sponsors
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Baghdad Medical City
OTHER
Al-Rasheed University College
OTHER
Responsible Party
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Principal Investigators
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Ali M Jawad, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad college of medicine
Bassam F Matti, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad Medical City
Tareq A Saleh, PhD
Role: STUDY_CHAIR
Baghdad Medical City
Mahammed S Abbas, PhD
Role: STUDY_DIRECTOR
Baghdad Medical City
Mohammed K Al-Qayyim, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad Medical City
Alaaldin S Naji, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad college of medicine
Ammer F Majid, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad Medical City
Adil S Al-Oqaby, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad Medical City
Mazin A Shubir, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad Medical City
Hawraa D Jumaa, PhD
Role: PRINCIPAL_INVESTIGATOR
Baghdad Medical City
Hayder A Fawzi, PhD
Role: PRINCIPAL_INVESTIGATOR
Al-Rasheed University College
Locations
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Baghdad Hematology center - Baghdad Medical City
Baghdad, Bab-Almuadham, Iraq
Countries
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Other Identifiers
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SEANM
Identifier Type: REGISTRY
Identifier Source: secondary_id
AR200103
Identifier Type: -
Identifier Source: org_study_id
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