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

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborators: Celgene; Celgene Corporation; Onyx Therapeutics, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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