NCT01171430

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

5.6 years

First QC Date

June 23, 2010

Last Update Submit

November 19, 2020

Conditions

Multiple Myeloma

Keywords

multiple myelomaAutologous Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Maximal percentage of bone marrow measurement on last WB DCE MRI

    Bone marrow enhancement : Enhancement (%) = (SIpost - SIpre) x 100/SIpre, where SIpre is the signal intensity before injection and SIpost is the signal intensity after injection

    Measurements will be performed on initialWB DCE MRI Examination. Follow-up = Five year

Secondary Outcomes (1)

  • Maximal percentage of bone marrow measurement on initial WB DCE MRI

    Measurements will be performed on initialWB DCE MRI Examination. Follow-up = Five year

Study Arms (1)

MRI WHOLE BODY

EXPERIMENTAL
Device: Whole Body Dynamic Contrast Enhanced MRI (WB-DCE-MRI)

Interventions

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

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).

Also known as: Mult.Myeloma eligible for Autologous Stem Cell Transpl.
MRI WHOLE BODY

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient referred to one of the hematology departement associated with the research project, with confirmed multiple myeloma defined according to uniform international criteria.
  • Whatever stage classification according to Salmon and Durie with a life expectancy of more than 3 months.
  • Age under 70 years old (amendment n°5) and eligible for autologous stem cell transplantation.
  • Free and informed consent.

You may not qualify if:

  • Patient unfit physically, mentally or legally to give informed consent.
  • Patient non affiliate with social security scheme
  • Patient with myeloma without measurable monoclonal immunoglobulin, including measurement of serum free light chains.
  • Patient with another malignancy excluding basal cell cancer.
  • Patient who could not undergo MRI (incompatible metallic foreign body, pacemaker, allergy to contrast, claustrophobia despite premedication, pregnancy, renal failure with creatinine clearance \<30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Alain Luciani

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2010

First Posted

July 28, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2019

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

FR(1)