Clinical trial NCT02405364: Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone Induction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Carfilzomib
Lenalidomide
Dexamethasone
Patient up to 65 years
initial management
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Onyx Therapeutics, Inc.
name: Celgene
First posted: 2015-04-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: rate of stringent complete response
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: CHRU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Nantes
country: France
facility: CHRU Hôtel Dieu
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Rennes
country: France
facility: Hôpital de Pontchaillou
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: University hospital of Toulouse
city: Tours
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: University Hospital of Toulouse
name: Michel ATTAL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Toulouse
name: Murielle ROUSSEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.