NCT00028600

Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 64 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

Detailed description

OBJECTIVES: * Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma. * Determine the response rate of patients treated with this regimen. * Determine the percent donor chimerism in patients treated with this regimen. * Determine the rate of graft-vs-host disease in patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine the disease-free and overall survival of patients treated with this regimen. * Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete. Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover. Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6. After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks. Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years. PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.

Conditions

• Multiple Myeloma
• Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC \>= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC \> 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2
BIOLOGICAL	CD34+ cells	2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant
DRUG	cyclophosphamide	4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep
DRUG	fludarabine phosphate	30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl
DRUG	melphalan	200mg/sq m IV infusion over 15-30 min D 2 auto transpl
DRUG	methotrexate	5mg/sq m/d IV infusion D 1,3,\& 6: allo transpl
DRUG	tacrolimus	0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150

Timeline

• Start date: 2001-11-01
• Primary completion: 2006-06-01
• Completion: 2010-02-01
• First posted: 2003-01-27
• Last updated: 2016-07-04

Locations

15 sites across 1 country: United States