Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
An Open Label Dose Escalation Study of Intravenous Paricalcitol (ZEMPLAR™) [19-NOR-1 ALPHA, 25 - (OH)D] With Zoledronic Acid (Zometa™) in Patients With Multiple Myeloma
RATIONALE: Paricalcitol may cause multiple myeloma cells to look more like normal cells, and
to grow and spread more slowly. Paricalcitol may also stop the growth of the cancer cells by
blocking blood flow to the cancer. Zoledronate may delay or prevent bone metastases in
patients with multiple myeloma. Giving paricalcitol together with zoledronate may be an
effective treatment for multiple myeloma or other plasma cell disorders.
PURPOSE: This clinical trial is studying the side effects and best dose of paricalcitol when
given with zoledronate in treating patients with relapsed or refractory multiple myeloma or
other plasma cell disorders.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of paricalcitol when used with zoledronate in
patients with relapsed or refractory multiple myeloma or other plasma cell disorders.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the antimyeloma activity of paricalcitol in patients treated with this
regimen.
OUTLINE: This is an open-label, dose-escalation study of paricalcitol.
Patients receive paricalcitol IV over 15 minutes on days 1, 8, and 15 and zoledronate IV
over 15 minutes on day 22. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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