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Autologous transplant with High Dose Melphalan alone

Melphalan plus Dexamethasone, Thalidomide, CisPlatinum, Adriamycin, Cyclophosphamide, and Etoposide

20mg/m2 continuous infusion days -3 and -2.

800 mg/m2 continuous infusion days -3 and -2.

Adriamycin

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.

200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K).

Frits van Rhee, M.D., Ph.D.

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.

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.

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

Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)

University of Arkansas

High Dose Melphalan

Mel-DT PACE

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Nathan M. Petty

only 2 participants in high dose (HD) melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.

Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation	NCT00083915	Multiple Myelom...	Cisplatin Cyclophosphamid... Adriamycin Etoposide Melphalan Thalidomide Dexamethasone	18 Years -	University of Arkansas
DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation	NCT00083915	Multiple Myelom...	Cisplatin Cyclophosphamid... Adriamycin Etoposide Melphalan Thalidomide Dexamethasone	18 Years -	University of Arkansas

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