Pilot Clinical Study of GCSF in Combination With Desipramine for Autologous Stem Cell Mobilization in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Success Rate of Stem Cell Mobilization (SCM) in Participants Who Failed Prior Mobilization or Who Were Exposed to Alkylator Therapy or Who Were Predicted to be Difficult to Mobilize Who Completed Filgrastim and Desipramine Therapy
研究概览
简要总结
This pilot clinical trial studied how well desipramine hydrochloride and filgrastim worked for stem cell mobilization in participants with multiple myeloma (MM) undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the participant's bone marrow to the blood so they can be collected and stored.
详细描述
PRIMARY OBJECTIVES:
I. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte colony-stimulating factor (GCSF) (filgrastim) with desipramine (desipramine hydrochloride) (G+D).
II. To analyze polymorphisms of adrenergic receptor beta 2 (ADRB2) and adrenergic receptor beta 3 (ADRB3) genes that correlate with mobilization efficiency.
OUTLINE:
Participants received desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection began on day 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for autologous stem cell transplant for multiple myeloma; planned use of filgrastim (GCSF) for stem cell mobilization
- •Ability to give informed consent
- •Glomerular filtration rate (GFR) > 30 ml/minute
- •Liver function tests < 2.5 x upper limit of normal (ULN)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or less
- •Based on prior therapy patients will be classified into two categories:
- •Initial mobilizers with no exposure to alkylators
- •Remobilizers or with prior exposure to alkylators or with greater than 5 cycles of lenalidomide therapy prior to mobilization
排除标准
- •Use of a monoamine oxidase inhibitor (MAO-I) during or within 2 weeks of desipramine therapy
- •Concomitant therapy with any drugs shown to have major interactions with desipramine
- •Concurrent use of drugs that are contraindicated with desipramine
- •Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death; baseline corrected QT (QTc) > 460 msec
- •Active alcohol abuse
- •Bipolar disorder
- •Untreated active major depression
- •History of seizures in the past 3 years
- •Pregnancy and lactation; refusal to use adequate contraception
- •Uncontrolled thyroid disease
- •GCSF or pegfilgrastim use within 14 days prior to enrollment
- •Bortezomib, Revlimid or thalidomide use within 7 days of enrollment
- •Patients with sickle cell disease
研究组 & 干预措施
Treatment (desipramine, filgrastim)
Participants received desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection began on day 6.
干预措施: Desipramine Hydrochloride (Drug)
Treatment (desipramine, filgrastim)
Participants received desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection began on day 6.
干预措施: Filgrastim (Biological)
Treatment (desipramine, filgrastim)
Participants received desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection began on day 6.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Failed Prior Mobilization or Who Were Exposed to Alkylator Therapy or Who Were Predicted to be Difficult to Mobilize Who Completed Filgrastim and Desipramine Therapy
时间窗: Day 5
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who Failed Prior Mobilization or who were Exposed to Alkylator Therapy or who were Predicted to be Difficult to Mobilize who completed the full course of filgrastim and desipramine and achieved the target collection of \>=5 x 10\^6 CD34+ cells/kg.
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
时间窗: Day 5
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of \>=5 x 10\^6 CD34+ cells/kg.
次要结局
- Median Time to Neutrophil Engraftment(Up to 1 week following completion of study treatment, up to 15 days)
- Incidence of Adverse Events(Up to 1 week following completion of study treatment, up to 15 days)
- Median Time to Platelet Engraftment(Up to 1 week following completion of study treatment, up to 15 days)
- Median Number of Days of Apheresis(Up to 1 week following completion of study treatment, up to 15 days)
研究者
Amit Verma
Principal Investigator
Albert Einstein College of Medicine