Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
1.PAD combination chemotherapy
- Bortezomib 1.3 mg/m2 will be given by intravenous bolus injection on days 1, 4, 8, 11
of each cycle. Oral or intravenous dexamethasone 40 mg will be administered on days 1-4
and 8-11 with doxorubicin 9 mg/m2 by intravenous bolus on days 1-4 of each cycle. The
cycle will be repeated every 3 weeks. A total of 2 cycles is planed before AHCT.
- For mobilization, G-CSF 10ug/kg/d alone will be given by subcutaneous injection from
day 12 of the second PAD cycle until completion of harvesting.
Melphalan 100 mg/m2/day will be administered on day -3 and day -2 for high-dose
-Maintenance :Thalidomide 100 - 200 mg/d for 2 years
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rates and toxicities.
To investigate the effectiveness of bortezomib, doxorubicin and dexamethasone (PAD) combination therapy in the treatment of previously untreated patients with multiple myeloma who are eligible for autologous hematopoietic cell transplantation (AHCT). The effectiveness will be evaluated in terms of response, response rates, and toxicities.
Jung-Hee Lee, professor
Asan Medical Center
Korea: Food and Drug Administration