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

University Hospital, Toulouse46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

Carfilzomib/Lenalidomide/DexamethasoneDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (11)

CHU Henri Mondor

Créteil, France

CHRU Dijon

Dijon, France

CHU Grenoble

Grenoble, France

Hôpital Claude Huriez

Lille, France

Outcomes

Primary Outcomes

rate of stringent complete response

completion of consolidation

Time frame: 12 months

Data from ClinicalTrials.gov

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