Newly Diagnosed Multiple Myeloma
Conditions
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.
Interventions
DRUGBortezomib 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)
Sponsors
Baghdad Medical City
Al-Rasheed University College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Iraq
Outcome results
None listed