Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00968396
First received: August 27, 2009
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.


Condition Intervention Phase
Multiple Myeloma
Procedure: Apheresis
Procedure: Stem Cell Transplantation
Drug: Melphalan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Neutrophil Engraftment Rate [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell Collection + Transplantation
Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1.
Procedure: Apheresis
On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation.
Procedure: Stem Cell Transplantation
Co-culture Stem Cell Infusion on Day 0.
Drug: Melphalan
100 mg/m^2 IV over 30 minutes daily on Days -2 and -1
Other Name: Alkeran

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy
  2. Age 18 to 75 years
  3. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias
  4. FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease
  5. Serum bilirubin </= 2 x upper limit of normal, SGPT </= 4 x upper limit of normal
  6. HIV-negative
  7. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
  8. Patient or guardian able to sign informed consent
  9. Marrow-MSC Donor Requirements: patients must have a family member who is matched at 2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC generation

Exclusion Criteria:

  1. International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin < 3.5 mg/L and albumin >/= 3.5 g/dL)
  2. Patients with an apheresis collection </= 7 x 10e6 CD34+/Kg
  3. A fully matched related donor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968396

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Yago Nieto, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00968396     History of Changes
Other Study ID Numbers: 2007-0886
Study First Received: August 27, 2009
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Myeloma
Ex-Vivo Depletion of Myeloma Cells
Peripheral Blood Progenitor Cell Grafts
PBPC
Stem Cell Transplant
Bone marrow stem cells
Melphalan
Alkeran
Apheresis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014