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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Carfilzomib/Lenalidomide/Dexamethasone

• Registration Number: NCT02405364
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-10-16
• Study Start: 2014-02
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-01
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Front line therapy	Carfilzomib/Lenalidomide/Dexamethasone	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

Primary Outcome Measures

Name	Time	Method
rate of stringent complete response	12 months	completion of consolidation

Trial Locations

Locations (11)

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

Hôpital Bretonneau; 🇫🇷 Tours, France

CHU de Toulouse; 🇫🇷 Toulouse, France

University hospital of Toulouse; 🇫🇷 Toulouse, France