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

Phase 4

Withdrawn

• Conditions: Newly Diagnosed Multiple Myeloma
• Interventions: Drug: Bortezomib 3.5 MG

• Registration Number: NCT04348006
• Lead Sponsor: Al-Rasheed University College

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction Therapy	Bortezomib 3.5 MG	Bortezomib will be administered as part of VCD or VRD protocols

Primary Outcome Measures

Name	Time	Method
Assessment the safety of Alvocade® therapy	During 6 months	Monitoring the rate of any adverse effect/event that will occur during the induction therapy
Assessment the effecacy of Alvocade® therapy	At end of 6 months	Assessment of overall response rate (ORR) of treatment after completion of induction protocol

Secondary Outcome Measures

Name	Time	Method
First assessment response	At end of 2 months	Assessment of response rate after 2 cycle from starting treatment protocol
Second assessment response	At end of 4 months	Assessment of response rate after 4 cycle from starting treatment protocol
Third assessment response	At end of 6 months	Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle)

Trial Locations

Locations (1)

Baghdad Hematology center - Baghdad Medical City; 🇮🇶 Baghdad, Bab-Almuadham, Iraq