Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 16, 2008

Primary Completion Date

April 21, 2014

Study Completion Date

April 21, 2014

Conditions
Multiple Myeloma and Plasma Cell NeoplasmNeurotoxicity
Interventions
DRUG

bortezomib

Given IV

DRUG

dexamethasone

Given orally

DRUG

melphalan

Given IV

DRUG

thalidomide

Given orally

GENETIC

cytogenetic analysis

Performed on baseline and post transplant bone marrow specimens

GENETIC

fluorescence in situ hybridization

Performed on baseline and post transplant bone marrow specimens

OTHER

laboratory biomarker analysis

Baseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years.

OTHER

questionnaire administration

Completed at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study.

PROCEDURE

autologous hematopoietic stem cell transplantation

Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan

PROCEDURE

peripheral blood stem cell transplantation

Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan

Trial Locations (1)

91010-3000

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER

NCT00792142 - Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma | Biotech Hunter | Biotech Hunter