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Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Plasma Cell Myeloma

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Trial Information

Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)


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

Inclusion Criteria


- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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 times 10(6) CD34 plus cells/kg in a single mob...

Principal Investigator

Claude Sportes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

120074

NCT ID:

NCT01547806

Start Date:

February 2012

Completion Date:

February 2015

Related Keywords:

  • Plasma Cell Myeloma
  • Autologous Hematopoietic Cell Transplantation
  • Plasma Cell Myeloma
  • Mobilization
  • Apheresis
  • Plerixafor
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892