Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma

Stage III Multiple Myeloma Clinical Trial

Official title: Phase II Study of PS-341 for Patients With High-Risk, Newly Diagnosed Multiple Myeloma

Status Completed

Clinical Trial Summary

This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the response rate to PS-341 (bortezomib) induction in patients with high risk, newly diagnosed multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate progression free survival. II. To explore the response rate of patients who relapse or progress on maintenance and then return to induction schedule.

III. To explore duration of second response.

TERTIARY OBJECTIVES:

I. To explore a possible differential response to PS-341 with previously described adverse prognostic indicators.

II. To explore specific gene expression profiles (GEP) that may predict response to therapy to an agent or combination of agents used in the treatment of newly diagnosed myeloma.

III. To explore specific post-treatment gene expression profiles (GEP) in the patients who have received 4 cycles of therapy and achieved a minimal response or better.

IV. To develop relevant information about the immune system for multiple myeloma patients treated with PS-341.

OUTLINE:

INDUCTION TREATMENT: Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 4 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
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

• NCT number: NCT00075881
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: January 2004
• Completion date: October 2012