Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-11 @ 2:44 AM
Study NCT ID:
NCT03234335
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2017-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], '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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non Relapse Mortality post-transplantation', 'timeFrame': '100 days post-transplantation', 'description': 'Non-relapse mortality at Day +100 post-transplantation will be reported.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years post-transplantation', 'description': 'Overall survival at 2 years post-transplantation will be reported.'}, {'measure': 'progression-free survival', 'timeFrame': '2 years post-transplantation', 'description': 'progression-free survival at 2 years post-transplantation will be reported.'}, {'measure': 'Number of toxicities', 'timeFrame': '2 years post-transplantation', 'description': 'Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.'}, {'measure': 'presence of hematological response', 'timeFrame': '6 months', 'description': 'The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.'}, {'measure': 'Level of renal response', 'timeFrame': '3 months, 6 months and one year', 'description': 'Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Renal Failure', 'Autologous Hematopoietic Stem Cell Transplantation (ASCT)', 'Melphalan'], 'conditions': ['Multiple Myeloma', 'Renal Failure']}, 'descriptionModule': {'briefSummary': 'Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.', 'detailedDescription': 'RI is associated with poor prognosis and short median survival (32 months vs 55 months for MM patients with normal renal function). Thus, RI remains a major challenge for hematologists, including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and quality of life. The combination of a proteasome inhibitor and an immunomodulator is the preferred induction treatment for newly diagnosed transplant-eligible MM patients. After induction, high-dose therapy with Autologous Stem Cell Transplant (ASCT) is the standard of care for these patients. However, concerns related to management of comorbidities and treatment side effects question about therapeutic options for patients with severe renal damage. Of interest, recent studies argued that high-dose therapy followed by ASCT could be a feasible and safe method for renal failure MM patients. Yet, these observations on small sample size patients groups need to be confirmed with standardized conditions. This study proposes to evaluate the efficacy and the safety of this therapeutic strategy in MM patients with severe renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≤ 66 years-old\n* Patients with symptomatic, measurable and newly diagnosed multiple myeloma associated:\n* Severe renal failure at the time of transplantation (creatinine clearance \\< 40 ml/min/1.73m², CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration)\n* Partial response after induction treatment\n* For patients who undergo autologous transplantation, absence of known contraindication for transplantation\n* Absence of amylose\n* Patient affiliated to a social security regimen or beneficiary of the same\n* Signed written informed consent form\n\nExclusion Criteria:\n\n* Patient without at least a partial hematological response following the induction stage\n* Medical history of previous malignancy\n* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)\n* Pregnant or breastfeeding woman\n* Declining participation"}, 'identificationModule': {'nctId': 'NCT03234335', 'acronym': 'IRMYG', 'briefTitle': 'High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment (IRMYG Study)', 'orgStudyIdInfo': {'id': '2017-0702'}, 'secondaryIdInfos': [{'id': '2017-A02180-53', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myeloma patients with severe renal impairment', 'description': 'Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation will be followed in this study, and data related to the pathology, treatments and transplantation will be reported.', 'armGroupLabels': ['Myeloma patients with severe renal impairment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Algiers', 'country': 'Algeria', 'facility': 'Centre Pierre et Marie Curie', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'city': 'Oran', 'country': 'Algeria', 'facility': 'EHU Oran', 'geoPoint': {'lat': 35.69906, 'lon': -0.63588}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Amiens', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': "Centre Hospitalier d'Argenteuil", 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Bayonne', 'country': 'France', 'facility': 'Centre Hospitalier de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Boulogne', 'country': 'France', 'facility': 'Centre Hospitalier de Boulogne', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14 000', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Cholet', 'country': 'France', 'facility': 'Centre Hospitalier de Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21 079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38 043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69 373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34 295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Saint-Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54 500', 'city': 'Nancy', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Archet', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75 005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75 013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75 020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75 020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69 495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86 021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Hôpital Saint-Bernard', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'Hôpital Victor Provo (Roubaix)', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '42 270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'city': 'Saint-Quentin', 'country': 'France', 'facility': 'Centre Hospitalier de Saint Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Jérôme Cornillon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}