Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Incidence and severity of systemic reactions
研究概览
简要总结
This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. A premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the safety and efficacy of a premedication regimen for motixafortide that includes loratadine, famotidine, acetaminophen, montelukast, and dexamethasone 12mg intravenously (IV) with an experimental regimen that replaces dexamethasone with methylprednisolone 125mg IV.
SECONDARY OBJECTIVES:
I. Compare the tolerability and patient experience between the regimens. II. Compare the effects of the two regimens on stem cell mobilization. III. Explore the potential immunomodulatory effects of the two regimens.
EXPLORATORY OBJECTIVE:
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The labels of the medications will be masked to the patient, the investigator, and the treating nurse.
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
- •Patients must be aged 18 years or older.
- •Patient must understand and voluntarily signed an informed consent form.
- •Patient must be willing and able to adhere to the study schedule and other protocol requirements.
- •Histologically confirmed multiple myeloma prior to enrollment and randomization.
- •Eligible for hematopoietic stem cell mobilization and autologous hematopoietic stem cell transplantation as per institutional guidelines.
- •Females of reproductive potential must use effective contraception during treatment with motixafortide and for 8 days after the final dose.
排除标准
- •Previous history of autologous or allogeneic hematopoietic cell transplantation.
- •History of hemoglobin SS disease or hemoglobin S trait precluding the patient's ability to use G-CSF.
- •History of steroid-induced psychosis or encephalopathy requiring medical intervention.
- •History of type I or II diabetes mellitus that is poorly controlled or with high glucose variability precluding safe administration of dexamethasone 12mg IV as premedication in the opinion of the investigator.
- •History of serious systemic reaction to motixafortide.
研究组 & 干预措施
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Montelukast (Drug)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Pheresis (Procedure)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Motixafortide (Drug)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Questionnaire Administration (Other)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Recombinant Granulocyte Colony-Stimulating Factor (Biological)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Pheresis (Procedure)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Questionnaire Administration (Other)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Biospecimen Collection (Procedure)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Recombinant Granulocyte Colony-Stimulating Factor (Biological)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Acetaminophen (Drug)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Electronic Health Record Review (Other)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Biospecimen Collection (Procedure)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Electronic Health Record Review (Other)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Montelukast (Drug)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Loratadine (Drug)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Acetaminophen (Drug)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Famotidine (Drug)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Loratadine (Drug)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Methylprednisolone (Drug)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Dexamethasone (Drug)
Arm I (Dexamethasone)
See Detailed Description
干预措施: Motixafortide (Drug)
Arm II (Methylprednisolone)
See Detailed Description
干预措施: Famotidine (Drug)
结局指标
主要结局
Incidence and severity of systemic reactions
时间窗: At day 4 and 5
Will compare the incidence and severity of systemic reactions after administration of motixafortide. Systemic reactions will be graded as per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Analysis will be based upon an intent-to-treat analysis of all subjects who are randomized to receive dexamethasone or methylprednisolone. Will evaluate the proportion of patients who develop systemic reactions stratified by grade associated with motixafortide between the two premedication regimens. The non-inferiority probability (p)-value between the two arms will be carried out using one-sided z-test. In addition, these two groups will be compared at patient level using chi-square test or Fisher's Exact test. A logistic regression will be used to estimate the odd ratio between the two arms controlling for the baseline covariates for an improved precision of the estimation.
Incidence and severity of injection site reactions
时间窗: At day 4 and 5
Will compare the incidence and severity of injection site reactions after administration of motixafortide. Injection site reactions will be graded as per CTCAE v5.0. The incidence of injection site reactions after administration of motixafortide between the two premedication regimens will be similarly compared to that of the incidence and severity of systemic reactions.
次要结局
- CD34+ hematopoietic stem and progenitor cells (HSPC)/kg collection(Up to day 8)
- Collection of >= 6 x 10^6 CD34+ HSPC/kg(At day 5)
- Cytokine levels(At days 4 and 5)
- Compare Tolerability Between Regimens(At days 4 and 5)
- CD34+ hematopoietic stem and progenitor cells (HSPC)/kg collection(Up to day 8)
- Collection of >= 6 x 10^6 CD34+ HSPC/kg(At day 5)
- Cytokine levels(At days 4 and 5)
研究者
Joseph Cataquiz Rimando
Principal Investigator
Emory University