NCT01370434

Two Cycles of PAD Combination by AHCT in MM

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Cooperative Study Group A for Hematology · Network
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	PAD combination	* Bortezomib 1.3 mg/m2/d iv on D 1, 4, 8, 11 * Doxorubicin 9 mg/m2/d iv on D 1-4 * Dexamethasone 40mg/d po or iv on D1-4, 8-11

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2011-06-10
• Last updated: 2011-06-10

Locations

1 site across 1 country: South Korea