NCT00719901

Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase I/II Trial of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma. Obatoclax and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose and recommended phase II dose of obatoclax mesylate when given in combination with bortezomib in patients with relapsed or refractory multiple myeloma. (Phase I) II. To evaluate the response rate (complete response, partial response, and very good partial response) in patients treated with this regimen. (Phase II) SECONDARY OBJECTIVES: I. To determine the duration of progression-free and overall survival of these patients. II. To evaluate the incidence of toxicities of this regimen in these patients. III. To explore the utility of genetic markers based on initial evidence that they are predictive of drug responsiveness and/or successful target inhibition. OUTLINE: This is a multicenter, phase I, dose-escalation study of obatoclax mesylate followed by a phase II study. Patients receive obatoclax mesylate IV over 3 hours and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	obatoclax mesylate	Given IV
DRUG	bortezomib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-04-01
• Completion: 2012-06-01
• First posted: 2008-07-22
• Last updated: 2015-01-12
• Results posted: 2013-12-09

Locations

1 site across 1 country: United States