NCT00258258终止1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Not specified
- •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
- •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
- •More than 4 weeks since prior high-dose steroids
- •No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders
- •No concurrent digoxin
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Paricalcitol and Gemcitabine in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00217477Roswell Park Cancer Institute34
已完成
2 期
Paricalcitol in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesLeukemiaNCT00064376Cedars-Sinai Medical Center
已完成
1 期
Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00238225Roswell Park Cancer Institute15
终止
2 期
Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone MetastasesMetastatic CancerProstate CancerNCT00634582Wake Forest University Health Sciences2
已完成
2 期
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary HyperparathyroidismSecondary HyperparathyroidismHemodialysisNCT00990704Abbott47