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

Summary

RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma.

PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm
• Neurotoxicity

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Firoozeh Sahebi, MD · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-16

Primary Completion

2014-04-21

Completion

2014-04-21

Countries

• United States

Study Locations