Status:
COMPLETED
Alteration in Timing of Plerixafor Administration
Lead Sponsor:
Emory University
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Autologous Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone m...
Eligibility Criteria
Inclusion
- Age 18-70 years
- MM patients in first or second complete or partial remission
- ECOG performance status of 0 or 1
- Up to 3 prior treatment regimens
- Meet all eligibility requirements for autologous transplant
- Adequate marrow function defined as WBC \>3,000; ANC \>1,500/mm3 ; Platelets \>75,000/mm3
- Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault
- Adequate liver function defined as AST/ALT/Bilirubin \< 2 times upper limit of normal
- Able to provide informed consent
- Women not pregnant and agree to use contraception
Exclusion
- High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
- Brain metastases or carcinomatous meningitis
- Previous treatment with high dose chemotherapy and autologous transplant.
- Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors.
- Acute infection or unexplained fever \>38°C
- Weight \> 175% of ideal body weight as defined by the Devine equation.
- Experimental therapy within 4 weeks
- Cytokine administration in the previous 14 days
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01149863
Start Date
June 1 2010
Last Update
December 13 2013
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322