Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant — CARAMEL 2  

Refractory Multiple Myeloma Clinical Trial

Official title: A Phase 2 Trial of Carfilzomib Consolidation After Autologous Stem Cell Transplantation for Multiple Myeloma(CARAMEL 2)

Status Withdrawn

Clinical Trial Summary

This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the complete response (CR) rate with carfilzomib and dexamethasone consolidation following an upfront single stem cell transplant (SCT).

SECONDARY OBJECTIVES:

I. To assess the toxicity of carfilzomib and dexamethasone when used as consolidation therapy in patients post SCT.

II. To determine the progression free rate at 1 and 2 years post SCT. III. To evaluate progression-free survival and overall survival.

TERTIARY OBJECTIVES:

I. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status.

II. To assess the HevyLite assay prior to and during treatment.

OUTLINE:

Patients receive carfilzomib intravenously (IV) over 30 minutes and dexamethasone orally (PO) on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 3 years and then every 6 months for 2 years. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

• NCT number: NCT01812720
• Study type: Interventional
• Source: Mayo Clinic
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2013
• Completion date: October 2014