Collection of Transplant Stem Cells for Plasma Cell Myeloma
Plasma Cell Myeloma, Multiple Myeloma
About this trial
This is an interventional treatment trial for Plasma Cell Myeloma focused on measuring Autologous Hematopoietic Cell Transplantation, Plasma Cell Myeloma, Mobilization, Apheresis, Plerixafor
Eligibility Criteria
- INCLUSION CRITERIA:
Multiple Myeloma Criteria:
Subjects with an indication for autologous hematopoietic cell transplant (AHCT) for the treatment of PCM as determined by the principal investigator (PI) or lead associate investigator (LAI).
- Subjects following induction treatment for plasma cell myeloma (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 to 18 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 (Eastern Cooperative Oncology Group ((ECOG) 0 or 1)
Ejection fraction (EF) by multigated acquisition scan (MUGA) or 2-D echocardiogram within institution normal limits. In case of low ejection fraction (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.
Hemoglobin (Hgb) greater than or equal to 8 g/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 New York Heart Association (NYHA), 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 patients 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
Human immunodeficiency virus (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 principal investigator (PI)/lead associate investigator (LAI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Hematopoietic Progenitor Cells (HPC)
Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.