Two Cycles of PAD Combination by AHCT in MM (PADinMM)
|ClinicalTrials.gov Identifier: NCT01370434|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: PAD combination||Phase 2|
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 chemotherapy.
-Maintenance :Thalidomide 100 - 200 mg/d for 2 years
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
No Intervention: VAD combination
Drug: PAD combination
- response rates and toxicities. [ Time Frame: 2.5 years ]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.
- hematologic recovery [ Time Frame: 2.5 years ]To evaluate the feasibility of harvesting peripheral blood stem cells (PBSC) and performing AHCT after 2 cycles of PAD in newly diagnosed MM. Cell counts of harvested PBSC and hematologic recovery after AHCT will be monitored
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370434
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736|
|Principal Investigator:||Jung-Hee Lee, professor||Asan Medical Center|