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NCT01163357
PHASE1

Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine phosphate and melphalan with or without total marrow irradiation in treating patients undergoing donor peripheral blood stem cell transplant for high-risk stage I or II multiple myeloma.

Official title: Phase I Study of Bortezomib With or Without Total Marrow Irradiation (TMI) Using Intensity Modulated Radiation Therapy (IMRT) in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With High Risk Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2011-03-01

Completion Date

2024-05-20

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

bortezomib

Given IV

DRUG

fludarabine phosphate

Given IV

OTHER

melphalan

Given IV

RADIATION

total marrow irradiation

Undergo TMI

DRUG

tacrolimus

Given IV and orally

DRUG

sirolimus

Given orally

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic PBSC transplant

OTHER

laboratory biomarker analysis

Correlative studies

Locations (1)

City of Hope

Duarte, California, United States