Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT01370434
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2011-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Cycles of PAD Combination by AHCT in MM
Sponsor:
Cooperative Study Group A for Hematology
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PADinMM
Brief Summary:
Based the proven efficacy and the ability to induce rapid response of various combinations of bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.
Detailed Description:
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: