Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone Induction

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Induction Followed by Autologous Stem Cell Transplantation, CRd Consolidation and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Old

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Carfilzomib/Lenalidomide/Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group 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: Pregnant or lactating females 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Front line therapy<br>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 | Drug: Carfilzomib/Lenalidomide/Dexamethasone<br>* 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)<br>* Other names: New drug combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of stringent complete response | completion of consolidation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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initial management, Multiple Myeloma, Carfilzomib, Lenalidomide, Dexamethasone, Patient up to 65 years