Paricalcitol and Zoledronate in Treating Patients With Relapsed or Refractory Multiple Myeloma or Other Plasma Cell Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Drug: paricalcitol
* Drug: zoledronic acid


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD) At least one previous treatment for MM or PCD required PATIENT CHARACTERISTICS: Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic Not specified Hepatic Not specified Renal Calcium ≤ 10.5 mg/dL No renal stone formation within the past 5 years for patients who have had curative therapy for a condition associated with the risk of stones (e.g., hyperparathyroidism, bladder dysfunction, obstructive uropathy) OR had a single episode of confirmed urolithiasis No calculi in urinary tract confirmed by renal ultrasonography, kidney, ureter, and bladder (KUB) x-ray, or other imaging modality Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No uncontrolled cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during study and for 3 months after study completion No osteonecrosis of the jaw No history of allergic reaction attributed to compounds of similar chemical or biological composition of calcitriol, paricalcitol, or zoledronate No uncontrolled intercurrent illness that would preclude study compliance No ongoing or active infection No psychiatric illness or social situation that may preclude study compliance PRIOR CONCURRENT THERAPY: Chemotherapy More than 4 weeks since prior chemotherapy Endocrine More than 4 weeks since prior high-dose steroids Other No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders No concurrent digoxin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paricalcitol|nan|
|Drug: zoledronic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory multiple myeloma