Collection of Transplant Stem Cells for Plasma Cell Myeloma

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01547806
First received: March 6, 2012
Last updated: March 14, 2014
Last verified: October 2013

March 6, 2012
March 14, 2014
February 2012
February 2015   (final data collection date for primary 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...
Same as current
Complete list of historical versions of study NCT01547806 on ClinicalTrials.gov Archive Site
Determine the proportion of subjects requiring addition of plerixafor to the G-CSF mobilization the proportion of subjects achieving the target or optimum goal of greater than or equal to 5 times 10(6) CD34 plus cells/kg in a single mobilization...
Same as current
Not Provided
Not Provided
 
Collection of Transplant Stem Cells for Plasma Cell Myeloma
Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)

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.

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 , 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 4 of mobilization will be evaluated in real time in each patient, based on the peripheral blood CD34 count on the morning of day 4 of filgrastim administration.

Study accrual over a 3-year period: 70 subjects

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Plasma Cell Myeloma
  • Drug: Filgrastim
    N/A
  • Drug: Plerixafor
    N/A
  • Procedure: Apheresis
    N/A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
February 2015
February 2015   (final data collection date for primary outcome measure)
  • 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.

Both
18 Years to 75 Years
No
Contact: Claude Sportes, M.D. (301) 435-5280 csportes@mail.nih.gov
Contact: Carl O Landgren, M.D. (301) 496-0670 ol20z@nih.gov
United States
 
NCT01547806
120074, 12-C-0074
Not Provided
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Carl O Landgren, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP