Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone Induction
NCT ID: NCT02405364
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2014-02-28
2019-11-25
Brief Summary
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Evaluation of the Safety and the Efficacy of Carfilzomib Combined With Cyclophosphamide and Dexamethasone (CCyd) or Lenalidomide and Dex (CRd) Followed by ASCT or 12 Cycles of Carf Combined With Dex and Len for Patients Eligible for ASCT With Newly Diagnosed Multiple Myeloma.
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Detailed Description
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It's a multicenter, open label, non randomized, phase II study. 46 patients will be enrolled.
Induction: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Stem Cell Harvest: High dose Cyclophosphamide with intensification consolidation: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Maintenance : Lenalidomide 13 cycles of 28 days
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Front line therapy
Induction: 4 cycles of 28 days of Carfilzomib/Lenalidomide/Dexamethasone Stem Cell Harvest+Intensification Consolidation 4 cycles of 28 days of Carfilzomib/ Lenalidomide/Dexamethasone Maintenance: Lenalidomide 13 cycles of 28 days
Carfilzomib/Lenalidomide/Dexamethasone
Induction:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Stem Cell harvest: HD Cyclophosphamide Intensification: HD Melphalan Consolidation:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Maintenance: Lenalidomide (13 cycles)
Interventions
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Carfilzomib/Lenalidomide/Dexamethasone
Induction:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Stem Cell harvest: HD Cyclophosphamide Intensification: HD Melphalan Consolidation:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Maintenance: Lenalidomide (13 cycles)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have symptomatic myeloma with at least one CRAB criteria
* Subjects must not have been treated previously with any systemic therapy for multiple myeloma
Exclusion Criteria
* Evidence of mucosal or internal bleeding and/or platelet refractory
* Acute active infection requiring treatment
* Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks
* Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy
* Subjects not eligible for high dose therapy
18 Years
65 Years
ALL
No
Sponsors
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Onyx Therapeutics, Inc.
INDUSTRY
Celgene
INDUSTRY
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Michel ATTAL, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Murielle ROUSSEL, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Locations
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CHU Henri Mondor
Créteil, , France
CHRU Dijon
Dijon, , France
CHU Grenoble
Grenoble, , France
Hôpital Claude Huriez
Lille, , France
CHRU Hôtel Dieu
Nantes, , France
Hôpital Saint-Antoine
Paris, , France
Hôpital de Pontchaillou
Rennes, , France
Hôpital de Hautepierre
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
University hospital of Toulouse
Toulouse, , France
Hôpital Bretonneau
Tours, , France
Countries
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References
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Landgren O, Kazandjian D, Roussel M, Jasielec J, Dytfeld D, Anderson A, Kervin TA, Iskander K, McFadden I, Jakubowiak AJ. Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies. Leuk Lymphoma. 2022 Oct;63(10):2413-2421. doi: 10.1080/10428194.2022.2068001. Epub 2022 May 12.
Roussel M, Lauwers-Cances V, Wuilleme S, Belhadj K, Manier S, Garderet L, Escoffre-Barbe M, Mariette C, Benboubker L, Caillot D, Sonntag C, Touzeau C, Dupuis J, Moreau P, Leleu X, Facon T, Hebraud B, Corre J, Attal M. Up-front carfilzomib, lenalidomide, and dexamethasone with transplant for patients with multiple myeloma: the IFM KRd final results. Blood. 2021 Jul 15;138(2):113-121. doi: 10.1182/blood.2021010744.
Other Identifiers
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12 568 03
Identifier Type: -
Identifier Source: org_study_id
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