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Trial record 78 of 495 for:    LENALIDOMIDE AND every 28 days

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02405364
Recruitment Status : Active, not recruiting
First Posted : April 1, 2015
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
Onyx Therapeutics, Inc.
Celgene
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Carfilzomib/Lenalidomide/Dexamethasone Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2014
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : December 2019


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 Name: New drug combination




Primary Outcome Measures :
  1. rate of stringent complete response [ Time Frame: 12 months ]
    completion of consolidation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405364


Locations
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France
CHU de Toulouse
Toulouse, France, 31000
University hospital of Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Onyx Therapeutics, Inc.
Celgene
Investigators
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Principal Investigator: Michel ATTAL, MD University Hospital of Toulouse
Principal Investigator: Murielle ROUSSEL, MD University Hospital of Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02405364     History of Changes
Other Study ID Numbers: 12 568 03
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
Multiple Myeloma
Carfilzomib
Lenalidomide
Dexamethasone
Patient up to 65 years
initial management
Additional relevant MeSH terms:
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Lenalidomide
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors