NCT02020941

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Attaya Suvannasankha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	carfilzomib	Given IV
DRUG	dexamethasone	Given IV or PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2013-12-25
• Last updated: 2016-11-02
• Results posted: 2016-11-02

Locations

1 site across 1 country: United States