A Pilot Study of Peripheral Blood Hematopoietic Stem Cell Mobilization With the Combination of Bortezomib and G-CSF in Multiple Myeloma and Non-Hodgkin's Lymphoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- >= 2 Fold Increase in Circulating PBSC's
研究概览
简要总结
This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin lymphoma patients.
详细描述
PRIMARY OBJECTIVES:
I. To estimate if addition of Bortezomib to the mobilization protocol will result with an increase in the levels of circulating peripheral blood stem cells (PBSCs) by at least 2-fold in blood and in the apheresis collections in up to 4-days collection protocol.
II. To assess whether time to neutrophil engraftment is 12 days or less, the historical value.
SECONDARY OBJECTIVES:
I. To test for co-mobilization of lymphoma or myeloma cells by bortezomib and G-CSF using real time polymerase chain reaction (PCR) for non-Hodgkin lymphoma (NHL) patients and by flow cytometry (cluster of differentiation [CD]38+/CD138+ cell) for multiple myeloma (MM) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Voluntary written informed consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •Diagnosis of B-type NHL or with multiple myeloma and eligible for autologous transplantation
- •No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy) and 4 weeks out of Bortezomib treatment for MM
- •Karnofsky performance status of > 50%
- •The patient has recovered from all acute toxic effects of prior chemotherapy
- •White blood cell (WBC) > 3.0 x 10^9/L
- •Absolute neutrophil count > 1.5 x 10^9/L
- •Platelet count > 100 x 10^9/L
- •Serum creatinine =< 2.2
- •Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) less than two times the upper limit of normal (ULN)
- •Total bilirubin less than two times the ULN
- •Left ventricle ejection fraction > 50% (by normal echocardiogram [ECHO] or multi gated acquisition scan [MUGA] scan)
- •Diffusing capacity of the lung for carbon monoxide (DLCO) > 50%
- •Forced vital capacity > 50% of predicted
- •Negative for human immunodeficiency virus (HIV)
- •Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential , agree to use 2 effective methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the time of signing the informed consent form through 30 days after the last dose of Bortezomib, or agree to completely abstain from heterosexual intercourse; women of child bearing potential agree to use an approved form of contraception; male subject, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse for the duration of the study
排除标准
- •Patient has a platelet count of < 100x 10^9/L within 14 days before enrollment
- •Patient has an absolute neutrophil count of ANC <1.5 x 10^9/L within 14 days before enrollment
- •Patient has creatinine of > 2.2 MG/DL within 14 days before enrollment
- •Patient has > 1.5 x ULN total bilirubin
- •Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
- •Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
- •Patient has hypersensitivity to Bortezomib, boron or mannitol
- •Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- •Participation in clinical trials with other investigational drugs not included in this trial, within 14 days before enrollment and throughout the duration of this trial
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •A co-morbid condition which, in the view of the investigators, renders the patient at high risk for this study
- •An acute medical condition resulting from prior chemotherapy
- •Brain metastases or carcinomatous meningitis
- •Acute infection
- •Fever (temp > 38 degrees Celsius [C]/100.4 degrees Fahrenheit [F])
- •Patients of child-bearing potential unwilling to implement adequate birth control
- •Patients who have deterioration of their clinical status or laboratory parameters between the time of enrollment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician or principal investigator
- •Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- •Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
研究组 & 干预措施
A Treatment (bortezomib and filgrastim)
GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF.
干预措施: filgrastim (Biological)
B Treatment (bortezomib and filgrastim)
GROUP B: Bortexomib administered on days 4 & day 7, before administration of filgrastim.
干预措施: filgrastim (Biological)
A Treatment (bortezomib and filgrastim)
GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF.
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
B Treatment (bortezomib and filgrastim)
GROUP B: Bortexomib administered on days 4 & day 7, before administration of filgrastim.
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
A Treatment (bortezomib and filgrastim)
GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF.
干预措施: bortezomib (Drug)
B Treatment (bortezomib and filgrastim)
GROUP B: Bortexomib administered on days 4 & day 7, before administration of filgrastim.
干预措施: bortezomib (Drug)
结局指标
主要结局
>= 2 Fold Increase in Circulating PBSC's
时间窗: Up to 6 months
Participants with \>= 2 fold increase in circulating PBSC's in blood and in apheresis collections in up to 4-days collection
次要结局
- Time to Neutrophil Engraftment(Up to 6 months)
研究者
Divaya Bhutani
Principal Investigator
Barbara Ann Karmanos Cancer Institute