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

Stopped early · Phase 1/Phase 2

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00719901

Run by

National Cancer Institute (NCI)

People needed

11

Starts

2008-07-01

Expected to finish

2012-06-01

Last updated by the study team

2015-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic multiple myeloma, meeting the following criteria at original diagnosis:
• Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
• Symptomatic disease (e.g.,anemia, hypercalcemia, bone disease, or renal dysfunction) that requires the initiation of therapy
• Measurable diseases assessed by one of the following:
• Monoclonal plasma cells detectable in the bone marrow
• Monoclonal serum spike detectable by serum protein electrophoresis or immunofixation
• Monoclonal protein detectable in the urine by electrophoresis or immunofixation
• Abnormal levels of the serum free light chains with an abnormal ratio between kappa and lambda
• Progressive disease after ≥ 1 prior therapy for myeloma
• Previously treated with ≤ 10 courses (30 weeks) of bortezomib and had no disease progression during therapy OR completed bortezomib therapy within the past 6 weeks
• No prior discontinuation of bortezomib therapy due to drug intolerance
• No known brain metastases
• No intracranial edema, intracranial metastasis, or active epidural disease
• Patients with lytic lesions of the cranium secondary to myeloma are eligible
• ECOG performance status 0-2
• Life expectancy > 6 months
• ANC ≥ 1,000/mm³
• Platelet count ≥ 50,000/mm³
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 2 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No peripheral neuropathy > NCI toxicity grade 2

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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