NCT02405364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Feb 2014

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

October 16, 2013

Last Update Submit

April 2, 2026

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaCarfilzomibLenalidomideDexamethasonePatient up to 65 yearsinitial management

Outcome Measures

Primary Outcomes (1)

  • rate of stringent complete response

    completion of consolidation

    12 months

Study Arms (1)

Front line therapy

EXPERIMENTAL

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

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)

Also known as: New drug combination
Front line therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU Henri Mondor

Créteil, France

Location

CHRU Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

Hôpital Claude Huriez

Lille, France

Location

CHRU Hôtel Dieu

Nantes, France

Location

Hôpital Saint-Antoine

Paris, France

Location

Hôpital de Pontchaillou

Rennes, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

University hospital of Toulouse

Toulouse, 31000, France

Location

Hôpital Bretonneau

Tours, France

Location

Related Publications (2)

  • 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.

    PMID: 33827114RESULT

  • Landgren O, Kazandjian D, Roussel M, Jasielec J, Dytfeld D, Anderson A, Kervin TA, Iskander K, McFadden I, Jakubowiak AJ. Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies. Leuk Lymphoma. 2022 Oct;63(10):2413-2421. doi: 10.1080/10428194.2022.2068001. Epub 2022 May 12.

    PMID: 35549810DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Michel ATTAL, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

  • Murielle ROUSSEL, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

April 1, 2015

Study Start

February 1, 2014

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)