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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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)
Baghdad Hematology center - Baghdad Medical City
Baghdad, Bab-Almuadham, Iraq
Assessment the safety of Alvocade® therapy
Monitoring the rate of any adverse effect/event that will occur during the induction therapy
Time frame: During 6 months
Assessment the effecacy of Alvocade® therapy
Assessment of overall response rate (ORR) of treatment after completion of induction protocol
Time frame: At end of 6 months
First assessment response
Assessment of response rate after 2 cycle from starting treatment protocol
Time frame: At end of 2 months
Second assessment response
Assessment of response rate after 4 cycle from starting treatment protocol
Time frame: 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)
Time frame: At end of 6 months
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