"WB-DCE-MRI" in Multiple Myeloma as an Independent Prognostic Factor for Disease-free Survival (EVALICEMM)
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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 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 |
- 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
- 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 2014 |
Estimated 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:
Other Name: Mult.Myeloma eligible for Autologous Stem Cell Transpl.
|
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 65 years old 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
Contact: Alain Luciani, MD, PhD | (0)1 49 81 26 34 ext +33 | alain.luciani@hmn.aphp.fr |
France | |
Henri Mondor Hospital | Recruiting |
Creteil, France, 94010 | |
Contact: Alain Luciani, MD, PhD (0)1 49 81 26 34 ext +33 alain.luciani@hmn.aphp.fr | |
Principal Investigator: Alain Luciani, MD, PhD |
Principal Investigator: | Alain Luciani | Assistance Publique - Hôpitaux de Paris |
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: | December 26, 2011 |
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 October 17, 2012