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

Toulouse University Hospital

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Carfilzomib/Lenalidomide/Dexamethasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02405364

12 568 03

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Front line therapy

Experimental group

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

Treatment:

Drug: Carfilzomib/Lenalidomide/Dexamethasone