NCT01309334

Brief Summary

Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P25-P50 for phase_3 multiple-myeloma

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_3 multiple-myeloma

Geographic Reach
1 country

17 active sites

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

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

2.6 years

First QC Date

March 4, 2011

Last Update Submit

August 22, 2014

Conditions

Multiple Myeloma

Keywords

MRIPET-scanmultiple myelomaprognosispharmacoeconomic analysis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with at least one lesion not detected on the MRI lesions

    At diagnosis

Secondary Outcomes (4)

  • Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment

    3 months and 7 months

  • Number of lesions at diagnosis

    Inclusion (diagnosis)

  • diffuse disease at diagnosis

    Diagnosis time (inclusion)

  • Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment

    Inclusion, 3 months and 7 months

Interventions

PET scanPROCEDURE

Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy

MRIPROCEDURE

Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy

Eligibility Criteria

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

You may qualify if:

  • symptomatic de novo multiple myeloma
  • less than 65 years of age
  • enrolled in the IFM/DFCI clinical trial

You may not qualify if:

  • years of age or more
  • not eligible for high-dose therapy
  • Cons-indications to MRI or PET-Scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Bordeaux University Hospital

Bordeaux, France

Location

Brest University Hospital "CHU du Morvan"

Brest, France

Location

Hospital "Côte de Nacre"

Caen, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Dijon University Hospital

Dijon, France

Location

Grenoble University Hospital "Hôpital Michallon"

Grenoble, France

Location

Le Mans Hospital

Le Mans, France

Location

Lille University Hospital "Claude Huriez"

Lille, France

Location

Lyon University Hospital

Lyon, France

Location

"Institut Paoli Calmettes"

Marseille, France

Location

Metz University Hospital "Hôpital de Mercy"

Metz, France

Location

Nancy University Hospita "Hôpitaux de Brabois"

Nancy, France

Location

Nantes University Hospital

Nantes, 44000, France

Location

APHP "Hôpital Saint-Antoine"

Paris, France

Location

Rennes University Hospital

Rennes, France

Location

Toulouse University Hospital

Toulouse, France

Location

Tours University Hospital "Hôpital Bretonneau"

Tours, France

Location

Related Publications (2)

  • Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodere F. Standardization of 18F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.

    PMID: 33151787DERIVED

  • Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodere F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.

    PMID: 33006656DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations

FR(17)