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

July 29, 2020 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • CHU de Toulouse
      • Toulouse, France, 31000
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Front line therapy
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
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)
Other Names:
  • New drug combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of stringent complete response
Time Frame: 12 months
completion of consolidation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Celgene
Onyx Therapeutics, Inc.

Investigators

  • Principal Investigator: Michel ATTAL, MD, University Hospital of Toulouse
  • Principal Investigator: Murielle ROUSSEL, MD, University Hospital of Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 568 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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