NCT00083915

DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation

University of Arkansas (UARK 2001-12), A Phase III Study of DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation in Patients With Active Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin or Platinol, Adriamycin or doxorubicin, Cyclophosphamide, and Etoposide. Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone.

Detailed description

To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with D.T. PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of complete remission (CR)/near CR/very good partial remission (VGPR) rate and event-free and overall survival.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cisplatin	20mg/m2 continuous infusion days -3 and -2.
DRUG	Cyclophosphamide	800 mg/m2 continuous infusion days -3 and -2.
DRUG	Adriamycin	20mg/m2 continuous infusion -3 and -2.
DRUG	Etoposide	80mg/m2 continuous infusion -3 and -2.
DRUG	Melphalan	200 mg/m2 IV over \<20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
DRUG	Thalidomide	200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K).
DRUG	Dexamethasone	40 mg po days 1 - 4 (4 days)

Timeline

• Start date: 2001-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2004-06-04
• Last updated: 2017-11-20
• Results posted: 2011-08-03

Locations

1 site across 1 country: United States