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| Name | Class |
|---|---|
| Onyx Therapeutics, Inc. | INDUSTRY |
| Celgene | INDUSTRY |
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The purpose is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.
The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Front line therapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib/Lenalidomide/Dexamethasone | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| rate of stringent complete response | completion of consolidation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel ATTAL, MD | University Hospital of Toulouse | Principal Investigator |
| Murielle ROUSSEL, MD | University Hospital of Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Henri Mondor | Créteil | France | ||||
| CHRU Dijon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33827114 | Result | 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. | |
| 35549810 |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C524865 | carfilzomib |
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|
|
| 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 | 31000 | France |
| University hospital of Toulouse | Toulouse | 31000 | France |
| Hôpital Bretonneau | Tours | France |
| Derived |
| 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. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |