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- WITHDRAWN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