A Phase I/II Trial of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma
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)
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
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of dose-limiting toxicity (DLT) incidents (Phase I)
DLT will be defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved Hematologic DLT measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.
Up to 21 days of every first course
United States: Food and Drug Administration
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