Multiple Myeloma Clinical Trial
Official title:
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
The study involves the use of a targeted form of radiation, in addition to standard high
dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted
radiation is designed to kill more multiple myeloma cells while avoiding the side effects of
standard radiation. This type of targeted radiation (also known as radioimmunotherapy) has
been approved by the Food and Drug Administration (FDA) for the treatment of a related
disease, lymphoma under the trade name, Zevalin©. Zevalin© has been added to high dose
chemotherapy and stem cell transplants for patients with lymphoma and is now being studied
in this clinical trial for patients with multiple myeloma. This trial is only available at
Tufts Medical Center.
The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe
and effective when integrated into a standard regimen of myeloablative chemotherapy and
autologous stem cell rescue in patients with measurable disease prior to high dose
chemotherapy and 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
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