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Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment

NCT01548573 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-06-14

Study results available
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Summary

This study is designed to decrease toxicity associated with prior tandem transplant protocols by reducing the intensity of induction, consolidation and maintenance therapy, while increasing event-free survival by adding bortezomib (Velcade®), thalidomide, gemcitabine and carmustine to the transplant regimens to down-regulate the rescue of myeloma cells by the micro-environment and to prevent DNA repair post high-dose alkylating agent therapy. By reducing drug resistance, it is hoped that 3-year event-free survival will be increased significantly when compared to Total Therapy II. Additionally, participants will have the option of providing biospecimens for a sub-study evaluating gene expression profiling at specific timepoints to better understand drug-resistance in myeloma, and to determine whether there are genes or gene products in the resistant population that can be targeted by novel therapies.

Conditions

Interventions

DRUG

Dexamethasone

Given PO

PROCEDURE

Tandem autologous stem cell transplant

DRUG

Cisplatin

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Cyclophosphamide

Given IV or PO

DRUG

Etoposide

Given IV

DRUG

Bortezomib

Given IV

DRUG

Thalidomide

Given PO

DRUG

Melphalan

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Iowa

    lead OTHER

Principal Investigators

  • Guido J Tricot, MD, PhD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-07-31
Completion
2014-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01548573 on ClinicalTrials.gov