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Front-line Therapy With Carfilzomib, Lenalidomide, and Dexamethasone Induction (IFM-CRd)

Primary Purpose

Multiple Myeloma

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Carfilzomib/Lenalidomide/Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Carfilzomib, Lenalidomide, Dexamethasone, Patient up to 65 years, initial management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU de Toulouse
University hospital of Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Front line therapy

Arm Description

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

Outcomes

Primary Outcome Measures

rate of stringent complete response

completion of consolidation

Secondary Outcome Measures

Full Information

NCT ID

NCT02405364

First Posted

October 16, 2013

Last Updated

July 29, 2020

Sponsor

University Hospital, Toulouse

Collaborators

Onyx Therapeutics, Inc., Celgene

1. Study Identification

Unique Protocol Identification Number

NCT02405364

Brief Title

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

Acronym

IFM-CRd

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

Collaborators

Onyx Therapeutics, Inc., Celgene

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Front line therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Carfilzomib/Lenalidomide/Dexamethasone

Other Intervention Name(s)

New drug combination

Intervention Description

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)

Primary Outcome Measure Information:

Title

rate of stringent complete response

Description

completion of consolidation

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel ATTAL, MD

Organizational Affiliation

University Hospital of Toulouse

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Murielle ROUSSEL, MD

Organizational Affiliation

University Hospital of Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Toulouse

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

University hospital of Toulouse

City

Toulouse

ZIP/Postal Code

31000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33827114

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.

Results Reference

derived

Learn more about this trial

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

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