Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: indium-111-ibritumomab tiuxetan; 90Y Zevalin
Intervention description: 1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging. 111In Zevalin will be administered by a 10 minute slow IV push injection immediately following completion of the rituximab infusion. 111In Zevalin may be injected by stopping the flow from the IV bag and injecting the radiolabeled antibody directly into the IV line. A 0.22 micron filter must be on line between the drug infusion port and the patient. The line must be flushed with at least 10cc of normal saline after 111In Zevalin has been injected.; Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi. 90Y Zevalin will be administered intravenously as a slow IV push over 10 minutes. 90Y Zevalin may be directly infused by stopping the flow from the IV bag and injecting the radiolabeled antibody directly into the IV line. A 0.22 micron filter must be on line between the syringe and the infusion port. The line must be flushed with at least 10cc normal saline after 90Y Zevalin has been infused.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Zevalin

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet established criteria for the diagnosis of multiple myeloma

          -  Durie-Salmon stage II or III disease

          -  Measurable disease in the serum and/or urine

          -  Scheduled to receive high dose chemotherapy and autologous stem cell transplant for
             multiple myeloma

          -  Individuals who have previously undergone autologous stem cell transplant are eligible
             for this study provided more than 6 months have elapsed from the prior transplant.

          -  Minimum stem cell dose of 4x106 CD34+ MNC / kg stored for autologous stem cell rescue.

          -  Adequate hematologic reserve as evidenced by ANC ≥ 1500/mm3 and platelets ≥
             100,000/mm3.

          -  Serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 3x institution upper limit of
             normal.

          -  Serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or
             measured).

        Exclusion Criteria:

          -  Stage I or smoldering myeloma, isolated plasmacytoma, or benign monoclonal gammopathy

          -  Non-secretory multiple myeloma

          -  Pregnant or lactating women

          -  Males and females who do not agree to practice approved methods of birth control for
             the duration of the study

          -  Presence of active infection

          -  Receipt of previous radiation therapy to critical organs exceeding any of the
             following limits: kidney 500 cGy, liver 1000 cGy, lungs 500 cGy