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Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib

NCT02489500 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-09-10

Study results available
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Summary

Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant.

This study will compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.

Conditions

  • AL Amyloidosis

Interventions

DRUG

Bortezomib

Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1

DRUG

Melphalan

Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0

DRUG

Neupogen

granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

PROCEDURE

Stem Cell Collection

collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

PROCEDURE

Stem cell infusion

infusion of previously collected autologous stem cells

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Vaishali Sanchorawala, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-04-28
Completion
2017-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02489500 on ClinicalTrials.gov