SWOG-9321 Melphalan, TBI, and Transplant vs Combo Chemo in Untreated Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

899

Participants

Timeline

Start Date

January 31, 1994

Primary Completion Date

October 31, 2003

Study Completion Date

November 30, 2006

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

recombinant interferon alfa

"3 million units/m2 SQ Monday-Wednesday~-Friday (3 times a week)"

DRUG

carmustine

20 mg/m2 I.V. day 1 q 35 days

DRUG

cyclophosphamide

1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)

DRUG

dexamethasone

40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks

DRUG

doxorubicin hydrochloride

10 mg/m2/day continuous 1 - 4 q 5 weeks

DRUG

melphalan

140 mg/m2 is given IV within 30 minutes of constitution on Day -5

DRUG

prednisone

40 mg/m2 PO days 1-7 q 35 days

DRUG

vincristine sulfate

0.5 mg/day continuous 1 - 4 q 5 weeks

PROCEDURE

allogeneic bone marrow transplantation

day 0

PROCEDURE

autologous bone marrow transplantation

day 0

PROCEDURE

peripheral blood stem cell transplantation

day 0

RADIATION

radiation therapy

administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)

Trial Locations (34)

10010

Veterans Affairs Medical Center - New York, New York

10016

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York

10461

Albert Einstein Comprehensive Cancer Center, The Bronx

14642

University of Rochester Cancer Center, Rochester

19111

Fox Chase Cancer Center, Philadelphia

46202

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis

48106

CCOP - Ann Arbor Regional, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

53295

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee

54449

CCOP - Marshfield Medical Research and Education Foundation, Marshfield

55416

CCOP - Metro-Minnesota, Saint Louis Park

55455

University of Minnesota Cancer Center, Minneapolis

55805

CCOP - Duluth, Duluth

55905

Mayo Clinic Cancer Center, Rochester

60201

CCOP - Evanston, Evanston

60611

Veterans Affairs Medical Center - Lakeside Chicago, Chicago

61602

CCOP - Illinois Oncology Research Association, Peoria

61801

CCOP - Carle Cancer Center, Urbana

70121

CCOP - Ochsner, New Orleans

85259-5404

CCOP - Scottsdale Oncology Program, Scottsdale

80209-5031

CCOP - Colorado Cancer Research Program, Inc., Denver

33612-9497

H. Lee Moffitt Cancer Center and Research Institute, Tampa

60611-3013

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago

46202-5289

Indiana University Cancer Center, Indianapolis

50309-1016

CCOP - Iowa Oncology Research Association, Des Moines

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

02111

New England Medical Center Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

49007-3731

CCOP - Kalamazoo, Kalamazoo

44106-5065

Ireland Cancer Center, Cleveland

43623-3456

CCOP - Toledo Community Hospital Oncology Program, Toledo

17822-2001

CCOP - Geisinger Clinic and Medical Center, Danville

19102-1192

Hahnemann University Hospital, Philadelphia

15213-3489

University of Pittsburgh Cancer Institute, Pittsburgh

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Cancer and Leukemia Group B

NETWORK

collaborator

Eastern Cooperative Oncology Group

NETWORK

lead

SWOG Cancer Research Network

NETWORK