A Phase II, Safety and Efficacy Study of Fixed Dose Radioimmunotherapy (Zevalin, Yttrium-90 Ibritumomab Tiuxetan) for Patients With Incomplete Response to Chemotherapy Prior to Autologous Stem Cell Transplant for Multiple Myeloma
Patients with multiple myeloma measurable disease following stem cell mobilization with
institution standard high dose cyclophosphamide and peripheral blood stem cell collection
are candidates for participation on this trial. 90Y Zevalin targets CD20 expressed on the
surface of mature B-cells and is FDA approved for relapsed/refractory low grade lymphoma.
This is a single arm, phase II safety and efficacy study of 90-Y Zevalin in multiple
myeloma. Subjects will receive cold antibody (Rituximab 100mg/m2) followed by 5 mCi test
dose of 111-In Zevalin on transplant day -21. Gamma camera images are obtained 48 to 72
hours after 111-In Zevalin to document appropriate / expected distribution of radiotracer.
On transplant day -14, subjects will receive another cold antibody dose followed by 90Y
Zevalin 0.4 mg/kg (max 32 mCi) as single dose. Subjects are admitted for transplant on day
-3 and proceed with institution standard high dose melphalan (200mg/m2) on day -2. Subjects
are followed for safety for 6 weeks after transplant.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety (rate of occurrence of defined toxic events) and Efficacy (objective response rate)
For efficacy, the objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy will be determined. For safety, the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant will be determined. The intervention will be considered safe if the rate of toxic events is less than 20%.
Throughout the study
Andreas K Klein, MD
Tufts Medical Center
United States: Institutional Review Board
|Tufts Medical Center||Boston, Massachusetts 02111|