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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02405364

Acronym

IFM-CRd

Enrollment

Registered

2015-04-01

Start date

2014-02-01

Completion date

2019-11-25

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Carfilzomib, Lenalidomide, Dexamethasone, Patient up to 65 years, initial management

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

Interventions

DRUGCarfilzomib/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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
rate of stringent complete response	12 months	completion of consolidation

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMichel ATTAL, MD

University Hospital of Toulouse

PRINCIPAL_INVESTIGATORMurielle ROUSSEL, MD