The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in mean pain level for each group following therapy
研究概览
简要总结
This early phase I trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (G-CSF) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients.
SECONDARY OBJECTIVES:
I. To examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain.
II. To identify risk factors associated with developing filgrastim induced bone pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient must be able to provide informed consent
- •Patients with confirmed diagnosis of multiple myeloma
- •Able to swallow and retain oral medication
- •All ethnic groups are eligible
排除标准
- •Non-English speaking person
- •Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
- •Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
- •Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
- •On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study
研究组 & 干预措施
Cohort I (loratadine)
Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
干预措施: Loratadine (Drug)
Cohort I (loratadine)
Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Cohort II (placebo)
Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo (Other)
Cohort II (placebo)
Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in mean pain level for each group following therapy
时间窗: Baseline up to 5 days after completion of stem cell mobilization
Pain severity will be measured at baseline and following treatment using a 10-point scale, with higher numbers indicating greater degrees of pain. Will compare the difference in mean pain level for each group following therapy.
次要结局
未报告次要终点
研究者
Mansi Shah, MD
Assistant Professor of Medicine
Rutgers Cancer Institute of New Jersey