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Bortezomib Before Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT00995059 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-01-05

No results posted yet for this study

Summary

Rationale: Giving bortezomib and low doses of chemotherapy and total-body irradiation before a donor stem cell transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving sirolimus and tacrolimus before and after transplant may stop this from happening.

Purpose: This phase I/II trial is studying the side effects and best dose of bortezomib before donor stem cell transplant in treating patients with multiple myeloma.

Conditions

Interventions

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo transplantation

PROCEDURE

allogeneic bone marrow transplantation

Undergo transplantation

DRUG

bortezomib

Given IV

DRUG

melphalan

Given IV

DRUG

anti-thymocyte globulin

Given IV

DRUG

sirolimus

Given orally

DRUG

tacrolimus

Given oral or IV

RADIATION

total-body irradiation

Undergo total-body irradiation

Sponsors & Collaborators

Principal Investigators

  • Martha Q. Lacy, M.D. · Mayo Clinic

  • James L. Slack, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995059 on ClinicalTrials.gov