Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
- Conditions
- Multiple MyelomaPlasma Cell Neoplasm
- Interventions
- Biological: filgrastimBiological: CD34+ cells
- Registration Number
- NCT00028600
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Autologous + Allogeneic Transplant filgrastim autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma Autologous + Allogeneic Transplant CD34+ cells autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma Autologous + Allogeneic Transplant cyclophosphamide autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma Autologous + Allogeneic Transplant fludarabine phosphate autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma Autologous + Allogeneic Transplant tacrolimus autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma Autologous + Allogeneic Transplant methotrexate autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma Autologous + Allogeneic Transplant melphalan autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
- Primary Outcome Measures
Name Time Method Treatment-related mortality 6 months
- Secondary Outcome Measures
Name Time Method Respone Rate 2-4 wks prior, and 3,6 mon then q 3 mon for 3 yrs, post allo transpl, then q 6 mon for max 15 yrs from study entry GVHD Incidence post allo transpl, & pre & post DLI Survival 2 years Overall and disease free survival will be assessed
Correlation of cytogenetics and response 6, 12 mon then q 1 yr for 3 yrs post allo transpl Treatment Completion Rate post treatment Chimerism Rate 1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI
Trial Locations
- Locations (15)
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
🇺🇸St Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States