A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2009

Conditions
Multiple Myeloma
Interventions
DRUG

Thalidomide

Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

DRUG

Dexamethasone

Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.

DRUG

DOXIL

DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.

Trial Locations (58)

Unknown

Fountain Valley

Greenbrae

La Verne

Los Angeles

Denver

New London

Boca Raton

Jacksonville

Miami

Orange City

Ormond Beach

Lawrenceville

Chicago

Indianapolis

Wichita

Baltimore

Bethesda

Minneapolis

Saint Louis Park

Columbia

Kansas City

Omaha

Englewood

Hackensack

Jersey City

Voorhees Township

Albany

Armonk

Box 302

Brooklyn

Nyack

The Bronx

Valhalla

Durham

Winston-Salem

Cleveland

Oklahoma City

Tulsa

Eugene

Pittsburgh

Wynnewood

Columbia

Easley

Sumter

Memphis

Nashville

Bedford

Dallas

Fort Worth

Fredericksburg

Houston

Burlington

Fairfax

Norfolk

Richmond

Spokane

Vancouver

Yakima

All Listed Sponsors
collaborator

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

INDUSTRY

lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT00097981 - A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma | Biotech Hunter | Biotech Hunter