View Clinical Trial (Medical Research Study)
Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Plasma Cell Myeloma |
| Purpose: |
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Background:
- 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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| Study Summary: |
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Background:
High-dose chemotherapy followed by autologous hematopoietic cell transplant (AHCT) remains a
critical part of the Plasma Cell Myeloma (PCM) treatment in subjects eligible for the
procedure. The timing of the procedure however, has become more controversial recently. This
protocol will allow collection of Hematopoietic Progenitor Cells by Apheresis (HPC,
Apheresis) in potential candidates for various PCM protocols at the Clinical Center.
The mobilizing agent plerixafor (Mozobil(Registered Trademark), Genzyme) has been recently
approved by the FDA for mobilization in PCM. However, the best and most cost effective
strategy for its use remains to be defined.
Objectives:
Evaluate the overall validity of an HPC mobilization strategy (with G-CSF alone or in
combination with plerixafor) using a formula calculating the likelihood of collecting
greater than or equal to 5 time 10(6) CD34 plus cells/kg in a single mobilization cycle.
Collect mobilized Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) prior to AHCT
for PCM
Eligibility:
Subjects with a possible indication for AHCT for the treatment of newly diagnosed PCM.
Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the
treatment of the PCM.
Design:
Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in
various clinical protocols.
Mobilization will be provided by a 5-daily administration of filgrastim according to
standard procedure.
The need for an additional mobilizing agent (plerixafor) to be given on day 5 of
mobilization will be evaluated in real time in each patient, based on the peripheral blood
CD34 count on the morning of day 5 of filgrastim administration.
Study accrual over a 3-year period: 70 subjects
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| Criteria: |
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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.
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| NCT ID: |
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NCT01547806 |
| Primary Contact: |
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Principal Investigator
Claude Sportes, M.D.
National Cancer Institute (NCI)
Claude Sportes, M.D.
Phone: (301) 435-5280
Email: kastensc@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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