Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy

Refractory Multiple Myeloma Clinical Trial

Official title: A Phase 2 Study of Carfilzomib and Bone Metabolism in Patients With Multiple Myeloma in First Relapse or Refractory to First Line Therapy

Status Terminated

Clinical Trial Summary

This phase II trial studies how well carfilzomib works in treating patients with multiple myeloma in first relapse or refractory to first-line therapy. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the overall response rate of carfilzomib after 8 cycles of treatment in patients with first-relapsed myeloma.

SECONDARY OBJECTIVES:

I. To assess the overall response rate to single agent carfilzomib after 4 cycles of treatment.

II. To assess progression-free survival (PFS). III. To assess time to progression (TTP). IV. To assess duration of response (DOR). V. To assess toxicities.

TERTIARY OBJECTIVES:

I. To examine the effect of carfilzomib alone or in combination with dexamethasone on the following biologic end points and their correlation with response: measurements of bone remodeling (sodium fluoride F 18 positron emission tomography [PET], serum markers of bone remodeling and the bone marrow osteoblastic and osteoclastic differentiation and function) with the measurement of disease response and proteasome activity in the bone marrow microenvironment.

II. To describe recapture of response after progression in the maintenance phase.

OUTLINE:

TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than partial response (PR) also receive dexamethasone orally (PO) or IV weekly in courses 4-8.

MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months. ;

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

• NCT number: NCT02020941
• Study type: Interventional
• Source: Indiana University
• Status: Terminated
• Phase: Phase 2
• Start date: September 2013
• Completion date: April 2016