NCT00580372

UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma

Phase II Study of Intensive "TOTAL THERAPY" for Untreated or Minimally Treated Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This experimental study evaluates the effects of a series of intensive drug regimens as initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4-6 months apart in support of high-dose Melphalan, followed by Interferon treatment indefinitely.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	VAD	3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
DRUG	High-Dose cyclophosphamide	Approximately 5-6 weeks after VAD 2 or 3: Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1
PROCEDURE	Hemopoietic stem cell procurement	Collection target = 10 x 10\^6 cells/kg
DRUG	EDAP	Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5
PROCEDURE	Autologous Hemopoietic Stem Cell Transplant 1	4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2
PROCEDURE	Autologous Hemopoietic Stem Cell Transplant 2	4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2
DRUG	Maintenance	3 months after Transplant 2: Intron A 3 X 10\^6 units /m2 M-W-F subcutaneously until relapse

Timeline

• Start date: 2002-08-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2007-12-24
• Last updated: 2016-09-20
• Results posted: 2016-09-20

Locations

1 site across 1 country: United States