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"WB-DCE-MRI" in Multiple Myeloma as an Independent Prognostic Factor for Disease-free Survival

NCT01171430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-11-20

No results posted yet for this study

Summary

The main objective of this study is to examine if absence of a satisfactory response on DCE-WB-MRI (see MR criteria of responders section) after completion of HDT followed by autologous stem-cell transplantation (ASCT) is an independent prognostic factor for EFS in patients with MM, compared with established ones including beta2-microglobulin and cytogenetic abnormalities. Secondary objectives are to examine if the microcirculation parameters obtained from baseline DCE-WB-MRI have prognostic significance and to examine if early DCE-WB-MRI performed after the induction HDT and before ASCT might also provide independent prognostic information for patient outcome, which might help in patient stratification and be integrated into the response criteria in the future.

Conditions

Interventions

DEVICE

Whole Body Dynamic Contrast Enhanced MRI (WB-DCE-MRI)

3 Whole Body Dynamic Contrast Enhanced MRI: * 1 WB-DCE-MRI before induction of chemotherapy(initial MRI). * 1 WB-DCE-MRI after induction high dose therapy and before intensification of chemotherapy and auto-transplant of hematopoietic sterns cells (early MRI). * 1 WB-DCE-MRI 3 months after treatment whatever (amendment n°3) (delayed MRI).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alain Luciani · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2016-02-29
Completion
2019-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT01171430 on ClinicalTrials.gov