Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT01971658
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2013-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of three techniques for the quantification of urinary monoclonal components in patients with Newly Diagnosed Multiple Myeloma.', 'timeFrame': '17 month', 'description': 'The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma.\n\nUrinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE).\n\nThe objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques.'}], 'primaryOutcomes': [{'measure': 'Response assessment according to the criteria IMWG', 'timeFrame': '15-17 month', 'description': 'compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD'}], 'secondaryOutcomes': [{'measure': 'Response assessment according to the criteria IMWG', 'timeFrame': '15 - 17 month', 'description': 'compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG)'}, {'measure': 'Number of Adverse Events', 'timeFrame': '15-17 month', 'description': 'To evaluate the Safety of induction therapy'}, {'measure': 'Number of collected stem cell', 'timeFrame': '17 month'}, {'measure': 'Number of death', 'timeFrame': '17 month', 'description': 'To evaluate Overall and Progression-Free Survival'}, {'measure': 'Response assessment according to the criteria IMWG', 'timeFrame': '15-17 month', 'description': 'compare the Response assessment in both arms: Compare the following parameters after induction treatment with four courses of VTD or four courses of VCD the Partial remission rate (according to the criteria IMWG)'}, {'measure': 'Number of relapse according to the criteria IMWG', 'timeFrame': '17 month', 'description': 'Progression-Free Survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'Newly Diagnosed'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '38023148', 'type': 'DERIVED', 'citation': 'Rosinol L, Hebraud B, Oriol A, Colin AL, Rios Tamayo R, Hulin C, Blanchard MJ, Caillot D, Sureda A, Hernandez MT, Arnulf B, Mateos MV, Macro M, San-Miguel J, Belhadj K, Lahuerta JJ, Garelik MB, Blade J, Moreau P. Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma. Front Oncol. 2023 Nov 2;13:1197340. doi: 10.3389/fonc.2023.1197340. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma.\n\nEligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.', 'detailedDescription': "The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma.\n\nin each treatment arm there will be :\n\n1. Induction therapy : 4 cycles of VTD (21 days)or VCD\n2. Systematic stem cell harvest after cycle 3"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients newly diagnosed with symptomatic Multiple Myeloma (MM) patient\n\n1. \\- 18 ≤ age \\< 66 years\n2. \\- Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2\n3. \\- Patients must be eligible for Autologous Stem Cell Transplantation\n4. \\- Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day\n5. \\- Female patients of child-bearing potential (FCBP):\n\n * Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence.\n * Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.\n6. \\- Male Patients:\n\n * Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy\n * Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy\n7. \\- All patients must:\n\n * Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy\n * Agree not to share study medication with another person.\n8. \\- Patients must be capable of giving informed consent\n9. \\- Patients must be affiliated with French social security system\n\nExclusion Criteria:\n\n1. \\- Asymptomatic Multiple myeloma\n2. \\- Non-secretory Multiple myeloma\n3. \\- Proven AL-amyloidosis\n4. \\- Age ≥ 66 years old\n5. \\- Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)\n6. \\- Radiation therapy in the 2 weeks preceding randomization\n7. \\- National Cancer Institute grade ≥ 2 peripheral neuropathy\n8. \\- Haemoglobin \\< 8g/dL\n9. \\- Absolute neutrophil count \\< 1,000 cells / µL, platelet count \\< 50,000 cells / µL\n10. \\- Creatinine level \\> 170 µmol/L or requiring dialysis.\n11. \\- Bilirubin, transaminases or GamaGT \\> 3 UNL (upper normal limit)\n12. \\- Positive HIV serology, evidence of active Hepatitis B and C infection\n13. \\- Severe active infection\n14. \\- Inability to comply with an anti-thrombotic treatment regimen\n15. \\- A personal medical history of severe psychiatric disease\n16. \\- Uncontrolled diabetes contraindicating the use of high-dose dexamethasone\n17. \\- Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)\n18. \\- A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation \\> or = 5 years (except for basocellular skin cancer or in situ cervical cancer)\n19. \\- Use of any investigational drug in the 30 days preceding randomization\n\n22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines'}, 'identificationModule': {'nctId': 'NCT01971658', 'acronym': 'IFM2013-04', 'briefTitle': 'Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."', 'orgStudyIdInfo': {'id': 'RC13_0284'}, 'secondaryIdInfos': [{'id': '2013-003174-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)', 'description': 'Arm A:\n\n1. Induction therapy 4 cycles of VTD (21 days) Thalidomide® 100 mg/day Per Os Day1 to Day21 Velcade® 1.3 mg/m²/day Subcutaneous Day1, 4, 8 and 11 Dexamethasone 40 mg/day Per Os Day 1 to 4 and Day 9 to 12\n2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and one week after the last dose of Thalidomide, stem cells have to be harvested', 'interventionNames': ['Drug: Thalidomide®', 'Drug: Velcade®', 'Drug: Dexaméthasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)', 'description': 'For arm B:\n\n1. Induction therapy : 4 cycles of VCD (21 days)\n\n * Cyclophosphamide 500 mg/m²/day, Per Os Day 1, 8, 15\n * Velcade® and Dexamethasone identical treatment to Arm A\n2. Systematic stem cell harvest after cycle 3 Mobilization: Cyclophosphamide and two weeks after the last dose of Cyclophosphamide, stem cells have to be harvested', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Velcade®', 'Drug: Dexaméthasone']}], 'interventions': [{'name': 'Thalidomide®', 'type': 'DRUG', 'armGroupLabels': ['VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)']}, {'name': 'Velcade®', 'type': 'DRUG', 'armGroupLabels': ['VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)', 'VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)']}, {'name': 'Dexaméthasone', 'type': 'DRUG', 'armGroupLabels': ['VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD)', 'VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'state': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '75651', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '74374', 'city': 'Annecy', 'state': 'Pringy', 'country': 'France', 'facility': "Centre Hospitalier de la région d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHRU Hôpital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '95 100', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier Argenteuil', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84902', 'city': 'Avignon', 'country': 'France', 'facility': 'Centre Hospitalier H.Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'Centre Hospitalier de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33 300', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Polyclinique Bordeaux Nord Aquitaine', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre hospitalier Pierre Oudot', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Hôpital A.Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '95303', 'city': 'Cergy-Pontoise', 'country': 'France', 'facility': 'CH René Dubos', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'zip': '71 321', 'city': 'Chalon/saone', 'country': 'France', 'facility': 'Centre Hospitalier William Morey'}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': "Hôpital d'instruction des armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "CHU d'Estaing", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hôpitaux civils de Colmar', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '94 010', 'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHRU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59 385', 'city': 'Dunkirk', 'country': 'France', 'facility': 'Centre Hospitalier Général', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHRU - Hôpital A.Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre hospitalier départemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '28000', 'city': 'Le Coudray', 'country': 'France', 'facility': 'Hôpital Louis Pasteur', 'geoPoint': {'lat': 48.42115, 'lon': 1.50057}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Jean Bernard', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Saint Vincent de Paul', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Hôpital Du Scorff', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '77104', 'city': 'Meaux', 'country': 'France', 'facility': 'Centre Hospitalier de Meaux', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz Thionville', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '78250', 'city': 'Meulan-en-Yvelines', 'country': 'France', 'facility': 'Centre Hospitalier intercommunale Meulan les mureaux', 'geoPoint': {'lat': 49.00768, 'lon': 1.90602}}, {'zip': '68100', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Hopital E Muller', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "Hôpital de l'Archet 1", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Groupe Hospitalo-Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut CURIE', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'CHU - Hôpital St-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66046', 'city': 'Perpignan', 'country': 'France', 'facility': 'CH Saint Jean', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'CHRU - Hôpital du Haut Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'facility': 'Centre Hospitalier de PERIGUEUX', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHRU - Hôpital Jean Bernard', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital R.Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHRU - Hôpital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '22 027', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Centre Hospitalier Yves le Foll', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '42 271', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie de la Loire', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '02 321', 'city': 'Saint-Quentin', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'zip': '35400', 'city': 'St-Malo', 'country': 'France', 'facility': 'Centre hospitalier', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHRU - Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHRU - Hôpitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '56017', 'city': 'Vannes', 'country': 'France', 'facility': 'CH Bretagne Atlantique Vannes et Auray', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Philippe MOREAU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}