This study is NOT currently recruiting participants.
Number
12-C-0074
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Max Age: 75
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Autologous Hematopoietic Cell Transplantation; Plasma Cell Myeloma; Mobilization; Apheresis; Plerixafor
Recruitment Keyword(s)
None
Condition(s)
Plasma Cell Myeloma; Multiple Myeloma
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Filgrastim Drug: Plerixafor Procedure/Surgery: Apheresis
Supporting Site
National Cancer Institute
- One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem cell transplant. Researchers want to collect stem cells from the blood for later transplant.
Objectives:
- To collect stem cells for transplant as part of treatment for plasma cell myeloma.
Eligibility:
- Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have filgrastim injections for 5 days before collection. This will move stem cells from the bone marrow to the blood.
- Participants will have apheresis to collect the stem cells.
- Participants who need additional apheresis procedures to collect stem cells will have filgrastim and a dose of plerixafor to improve the collection yield.
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INCLUSION CRITERIA: Multiple Myeloma Criteria: Subjects with an indication for AHCT for the treatment of PCM as determined by the PI or LAI. -Subjects following induction treatment for PCM -Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM. Other Eligibility Criteria: Age greater than or equal to18 years and less than or equal to 75 years. In subjects between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling. Karnofsky performance status of 70% or greater (ECOG 0 or 1) Ejection fraction (EF) by MUGA or 2-D echocardiogram within institution normal limits. In case of low EF, the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more. Hgb greater than or equal to 8g/dl (transfusion acceptable) No history of abnormal bleeding tendency. Patients must be able to give informed consent EXCLUSION CRITERIA: Prior allogeneic stem cell transplantation Hypertension not adequately controlled by 3 or less medications. Clinically significant cardiac pathology: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to NYHY, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Specifically, any history of cardio-vascular pathology or symptoms, not clearly fitting this exclusion criterion will prompt an evaluation by a Clinical Center Cardiologist and eligibility will be considered on a case-by-case basis. Should the cardiologist deem the patient s findings on work-up to be not clinically significant pathology, the patient will have met this exclusion criterion. Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis. Active hepatitis B or C infection HIV seropositive, with positive confirmatory nucleic acid test Patients known or found to be pregnant. Patients of childbearing age who are unwilling to practice contraception. Patients may be excluded at the discretion of the PI/LAI if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
Multiple Myeloma Criteria:
Subjects with an indication for AHCT for the treatment of PCM as determined by the PI or LAI.
-Subjects following induction treatment for PCM
-Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM.
Other Eligibility Criteria:
Age greater than or equal to18 years and less than or equal to 75 years. In subjects between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling.
Karnofsky performance status of 70% or greater (ECOG 0 or 1)
Ejection fraction (EF) by MUGA or 2-D echocardiogram within institution normal limits. In case of low EF, the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more.
Hgb greater than or equal to 8g/dl (transfusion acceptable)
No history of abnormal bleeding tendency.
Patients must be able to give informed consent
EXCLUSION CRITERIA:
Prior allogeneic stem cell transplantation
Hypertension not adequately controlled by 3 or less medications.
Clinically significant cardiac pathology: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to NYHY, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Specifically, any history of cardio-vascular pathology or symptoms, not clearly fitting this exclusion criterion will prompt an evaluation by a Clinical Center Cardiologist and eligibility will be considered on a case-by-case basis. Should the cardiologist deem the patient s findings on work-up to be not clinically significant pathology, the patient will have met this exclusion criterion.
Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
Active hepatitis B or C infection
HIV seropositive, with positive confirmatory nucleic acid test
Patients known or found to be pregnant.
Patients of childbearing age who are unwilling to practice contraception.
Patients may be excluded at the discretion of the PI/LAI if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
Principal Investigator
Referral Contact
For more information: