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

PHASE2CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Multiple Myeloma
Interventions
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

Trial Locations (1)

72205

University of Arkansas for Medical Sciences/MIRT, Little Rock

All Listed Sponsors
lead

University of Arkansas

OTHER

NCT00580372 - "UARK 89-001 Phase II Study of Intensive TOTAL THERAPY For Untreated or Minimally Treated Patients With Multiple Myeloma" | Biotech Hunter | Biotech Hunter