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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Melphalan

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

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

3. A fully matched related donor