Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00028600|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Plasma Cell Neoplasm||Biological: filgrastim Biological: CD34+ cells Drug: cyclophosphamide Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: tacrolimus||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||February 2010|
Experimental: Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
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
Other Name: G-CSF
Biological: CD34+ cells
2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant
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
200mg/sq m IV infusion over 15-30 min D 2 auto transpl
5mg/sq m/d IV infusion D 1,3,& 6: allo transpl
0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150
- Treatment-related mortality [ Time Frame: 6 months ]
- Treatment Completion Rate [ Time Frame: post treatment ]
- Respone Rate [ Time Frame: 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 ]
- Chimerism Rate [ Time Frame: 1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI ]
- GVHD Incidence [ Time Frame: post allo transpl, & pre & post DLI ]
- Survival [ Time Frame: 2 years ]Overall and disease free survival will be assessed
- Correlation of cytogenetics and response [ Time Frame: 6, 12 mon then q 1 yr for 3 yrs post allo transpl ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028600
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Delaware|
|Tunnell Cancer Center at Beebe Medical Center|
|Lewes, Delaware, United States, 19958|
|CCOP - Christiana Care Health Services|
|Newark, Delaware, United States, 19713|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Maryland|
|Union Hospital Cancer Program at Union Hospital|
|Elkton MD, Maryland, United States, 21921|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis|
|St Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, Pennsylvania|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital|
|Pittsburgh, Pennsylvania, United States, 15224-1791|
|Study Chair:||Kenneth C. Anderson, MD||Dana-Farber Cancer Institute|