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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01171430
First received: June 23, 2010
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Multiple Myeloma
Device: Whole Body Dynamic Contrast Enhanced MRI (WB-DCE-MRI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Dynamic Contrast Enhanced Whole Body MRI (DCE-WB-MRI) as Independent Prognostic Factor for Disease-free Survival in Multiple Myeloma (After Intensification Therapy and Autologous Stem Cell Transplantation Suppressed by Amendment n°3)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Maximal percentage of bone marrow measurement on last WB DCE MRI [ Time Frame: Measurements will be performed on initialWB DCE MRI Examination. Follow-up = Five year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Maximal percentage of bone marrow measurement on initial WB DCE MRI [ Time Frame: Measurements will be performed on initialWB DCE MRI Examination. Follow-up = Five year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 140
Study Start Date: July 2010
Estimated Study Completion Date: July 2019
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI WHOLE BODY 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).
Other Name: Mult.Myeloma eligible for Autologous Stem Cell Transpl.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171430

Locations
France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alain Luciani Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01171430     History of Changes
Other Study ID Numbers: P081236
Study First Received: June 23, 2010
Last Updated: August 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
multiple myeloma
Autologous Stem Cell Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014