Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT01208766
Status:
UNKNOWN
Last Update Posted:
2024-08-21
First Post:
2010-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'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': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1503}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2010-09-23', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).', 'timeFrame': 'end of trial (last patient last visit)', 'description': 'For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).'}, {'measure': 'For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first', 'timeFrame': 'end of trial (last patient last visit)', 'description': 'For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first'}, {'measure': 'For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first', 'timeFrame': 'end of trial (last patient last visit)', 'description': 'For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first'}], 'secondaryOutcomes': [{'measure': 'Overall survival measured from the time of registration /randomization R1/ randomization R2. Patients still alive or lost to follow up are censored at the date they were last known to be alive.', 'timeFrame': 'end of trial (last patient last visit)', 'description': 'Overall survival measured from the time of registration /randomization R1/ randomization R2.\n\nPatients still alive or lost to follow up are censored at the date they were last known to be alive.'}, {'measure': 'Toxicity', 'timeFrame': 'End of trial (last patient last visit)', 'description': 'Toxicity'}, {'measure': 'Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.', 'timeFrame': 'end of trial (last patient last visit)', 'description': 'Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Multiple Myeloma (Kahler's disease)"], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '38062124', 'type': 'DERIVED', 'citation': 'Mai EK, Hielscher T, Bertsch U, Salwender HJ, Zweegman S, Raab MS, Munder M, Pantani L, Mancuso K, Brossart P, Beksac M, Blau IW, Durig J, Besemer B, Fenk R, Reimer P, van der Holt B, Hanel M, von Metzler I, Graeven U, Muller-Tidow C, Boccadoro M, Scheid C, Dimopoulos MA, Hillengass J, Weisel KC, Cavo M, Sonneveld P, Goldschmidt H. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. Leukemia. 2024 Mar;38(3):640-647. doi: 10.1038/s41375-023-02105-6. Epub 2023 Dec 7.'}, {'pmid': '35123422', 'type': 'DERIVED', 'citation': 'Schmitz A, Brondum RF, Johnsen HE, Mellqvist UH, Waage A, Gimsing P, Op Bruinink DH, van der Velden V, van der Holt B, Hansson M, Andersen NF, Frolund UC, Helleberg C, Schjesvold FH, Ahlberg L, Gulbrandsen N, Andreasson B, Lauri B, Haukas E, Bodker JS, Roug AS, Bogsted M, Severinsen MT, Gregersen H, Abildgaard N, Sonneveld P, Dybkaer K. Longitudinal minimal residual disease assessment in multiple myeloma patients in complete remission - results from the NMSG flow-MRD substudy within the EMN02/HO95 MM trial. BMC Cancer. 2022 Feb 5;22(1):147. doi: 10.1186/s12885-022-09184-1.'}, {'pmid': '34520219', 'type': 'DERIVED', 'citation': 'Sonneveld P, Dimopoulos MA, Beksac M, van der Holt B, Aquino S, Ludwig H, Zweegman S, Zander T, Zamagni E, Wester R, Hajek R, Pantani L, Dozza L, Gay F, Cafro A, De Rosa L, Morelli A, Gregersen H, Gulbrandsen N, Cornelisse P, Troia R, Oliva S, van de Velden V, Wu K, Ypma PF, Bos G, Levin MD, Pour L, Driessen C, Broijl A, Croockewit A, Minnema MC, Waage A, Hveding C, van de Donk NWCJ, Offidani M, Palumbo GA, Spencer A, Boccadoro M, Cavo M. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Nov 10;39(32):3613-3622. doi: 10.1200/JCO.21.01045. Epub 2021 Sep 14.'}, {'pmid': '32359506', 'type': 'DERIVED', 'citation': 'Cavo M, Gay F, Beksac M, Pantani L, Petrucci MT, Dimopoulos MA, Dozza L, van der Holt B, Zweegman S, Oliva S, van der Velden VHJ, Zamagni E, Palumbo GA, Patriarca F, Montefusco V, Galli M, Maisnar V, Gamberi B, Hansson M, Belotti A, Pour L, Ypma P, Grasso M, Croockewit A, Ballanti S, Offidani M, Vincelli ID, Zambello R, Liberati AM, Andersen NF, Broijl A, Troia R, Pascarella A, Benevolo G, Levin MD, Bos G, Ludwig H, Aquino S, Morelli AM, Wu KL, Boersma R, Hajek R, Durian M, von dem Borne PA, Caravita di Toritto T, Zander T, Driessen C, Specchia G, Waage A, Gimsing P, Mellqvist UH, van Marwijk Kooy M, Minnema M, Mandigers C, Cafro AM, Palmas A, Carvalho S, Spencer A, Boccadoro M, Sonneveld P. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study. Lancet Haematol. 2020 Jun;7(6):e456-e468. doi: 10.1016/S2352-3026(20)30099-5. Epub 2020 Apr 30.'}, {'pmid': '30561775', 'type': 'DERIVED', 'citation': 'Gambella M, Omede P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.'}], 'seeAlsoLinks': [{'url': 'http://www.hovon.nl', 'label': 'Hovon website'}]}, 'descriptionModule': {'briefSummary': 'Study phase: phase III\n\nStudy objective:\n\n* Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT)\n* Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation\n* Comparison of single versus tandem high dose Melphalan with ASCT\n\nPatient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive\n\nStudy design: Prospective, multicenter, intergroup, randomized\n\nDuration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS (see appendix A), i.e. at least one of the CRAB criteria should be present;\n* Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein\\> 10 g/l or urine M-protein \\> 200 mg/24 hours), or abnormal free light chain ratio;\n* Age 18-65 years inclusive;\n* WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions);\n* Negative pregnancy test at inclusion if applicable;\n* Written informed consent.\n\nInclusion for randomisation 1:\n\n* WHO performance 0-2;\n* Bilirubin and transaminases \\< 2.5 times the upper limit of normal values;\n* A suitable stem cell graft containing at least 4 x 106 CD34+ cells/kg (or according to national guidelines).\n\nInclusion for randomisation 2:\n\n* Bilirubin and transaminases \\< 2.5 times the upper limit of normal values;\n* ANC \\>= 0.5 x 109/l and platelets \\> 20 x 10\\^9/l;\n* Patient is able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.\n\nExclusion Criteria:\n\n* Known intolerance of Boron;\n* Systemic AL amyloidosis;\n* Primary Plasmacell Leukemia;\n* Non-secretory MM;\n* Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control;\n* Severe cardiac dysfunction (NYHA classification II-IV);\n* Significant hepatic dysfunction, unless related to myeloma;\n* Patients with GFR \\<15 ml/min,\n* Patients known to be HIV-positive;\n* Patients with active, uncontrolled infections;\n* Patients with neuropathy, CTC grade 2 or higher;\n* Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;\n* Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);\n* Lactating women.\n\nExclusion for randomisation 1:\n\n* Severe pulmonary, neurologic, or psychiatric disease;\n* CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;\n* Allogeneic Stem Cell Transplantation (Allo SCT) planned;\n* Progressive disease.'\n\nExclusion for randomisation 2:\n\n* Progressive disease;\n* Neuropathy, except CTCAE grade 1;\n* CTCAE grade 3-4 polyneuropathy during Bortezomib treatment."}, 'identificationModule': {'nctId': 'NCT01208766', 'acronym': 'HO95', 'briefTitle': 'Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Stichting Hemato-Oncologie voor Volwassenen Nederland'}, 'officialTitle': 'A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma', 'orgStudyIdInfo': {'id': 'HOVON 95 MM'}, 'secondaryIdInfos': [{'id': '2009-017903-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'EMN02', 'type': 'OTHER', 'domain': 'European Myeloma Network'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)', 'description': 'All patients randomized to VMP treatment, will be treated with Bortezomib, Melphalan, Prednisone(VMP, 4 cycles) and will start intensification with VMP between 4 and 6 weeks after stem cell collection.', 'interventionNames': ['Drug: Bortezomib, Melphalan, Prednisone (VMP)']}, {'type': 'EXPERIMENTAL', 'label': 'R1: 1 (2) cycle(s) HDM', 'description': 'All patients randomized to intensification with High Dose Melphalan will start intensification with HDM (in hospitals with a policy of double intensification, patients will be randomized between VMP, 1 HDM and 2 HDM) between 4 and 6 weeks after stem cell collection.', 'interventionNames': ['Drug: 1 or 2 cycle(s) HDM (High Dose Melphalan)']}, {'type': 'NO_INTERVENTION', 'label': 'R2: none', 'description': 'No consolidation, patients will continue to Lenalidomide maintenance.'}, {'type': 'EXPERIMENTAL', 'label': 'R2: 2 cycles of VRD', 'description': 'In patients randomized to consolidation treatment, 2 cycles of Bortezomib, Lenalidomide,Dexamethasone (VRD) will start at 8 weeks after the end of the last course of VMP or HDM.', 'interventionNames': ['Drug: 2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)']}], 'interventions': [{'name': 'Bortezomib, Melphalan, Prednisone (VMP)', 'type': 'DRUG', 'description': '* Bortezomib \\_ 1.3 mg/m2 \\_ i.v. rapid infusion \\_ days 1,4,8,11,22,25,29,32\n* Melphalan \\_ 9 mg/m² \\_ p.o. \\_ days 1-4\n* Prednisone \\_ 60 mg/m² \\_ p.o. \\_ days 1-4', 'armGroupLabels': ['R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)']}, {'name': '1 or 2 cycle(s) HDM (High Dose Melphalan)', 'type': 'DRUG', 'description': '\\- Melphalan \\_ 100 mg/m² \\_ i.v. rapid infusion \\_ -3, -2\\*\n\n\\*Patients with renal insufficiency 100 mg/m2 only at day -3\n\nIf a patient is randomized to receive 2 x HDM a second course of High Dose Melphalan may be administered between 2 and 3 months after the first course when the patient achieved at least PR.', 'armGroupLabels': ['R1: 1 (2) cycle(s) HDM']}, {'name': '2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)', 'type': 'DRUG', 'description': '* Bortezomib \\_ 1.3 mg/m2 \\_ i.v. rapid infusion \\_ days 1,4,8,11\n* Lenalidomide \\_ 25 mg \\_ p.o. \\_ days 1-21\n* Dexamethasone \\_ 20 mg \\_ p.o. \\_ days 1,2,4,5,8,9,11,12', 'armGroupLabels': ['R2: 2 cycles of VRD']}]}, 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'facility': 'Krankenhaus d.Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Salzburg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'AT-Vienna-HANUSCH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'BE-Antwerpen Edegem-UZA', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'BE-Antwerpen-ZNASTUIVENBERG', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'BE-Haine-Saint-Paul-JOLIMONT', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'city': 'La Louvière', 'country': 'Belgium', 'facility': 'CHU Tivoli', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'BE-Liege-CHRCITADELLE', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, 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