Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients

Newly Diagnosed Multiple Myeloma Clinical Trial

— MM  

Official title:

Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04348006
• Other study ID #: AR200103
• Secondary ID: SEANM
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2023
• Source: Al-Rasheed University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A:

anemia, and B: bone lesions)

• Age above 18 years old

Exclusion Criteria:

• Age below 18 years

• Smoldering MM

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Multiple Myeloma

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Iraq	Baghdad Hematology center - Baghdad Medical City	Baghdad	Bab-Almuadham

Sponsors (2)

Lead Sponsor	Collaborator
Al-Rasheed University College	Baghdad Medical City

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment the safety of Alvocade® therapy	Monitoring the rate of any adverse effect/event that will occur during the induction therapy	During 6 months
Primary	Assessment the effecacy of Alvocade® therapy	Assessment of overall response rate (ORR) of treatment after completion of induction protocol	At end of 6 months
Secondary	First assessment response	Assessment of response rate after 2 cycle from starting treatment protocol	At end of 2 months
Secondary	Second assessment response	Assessment of response rate after 4 cycle from starting treatment protocol	At end of 4 months
Secondary	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