At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Expected survival ≥6 months
- ✓WHO performance status 0, 1, or 2
- ✓Newly diagnosed or relapsed/refractory myeloma (not more than 3 lines of prior therapy for relapsed disease)
- ✕Impaired bone marrow reserve: platelet count <100,000/mm³, hypocellular marrow, marked reduction in cell line precursors, failed stem cell collection, or MDS
- ✕Prior radioimmunotherapy or prior anti-CD20 therapy
- ✕Other malignancy except skin cancer or cervical/breast in situ, unless cancer-free >3 years
- ✕CNS involvement
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Iodine I 131 Tositumomab for Multiple Myeloma. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This study is for patients with newly diagnosed or relapsed multiple myeloma. The main purpose of this study is to see how their disease responds to consolidation treatment (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein) called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side effects which occur with this type of treatment. The investigators will also be looking at how long disease responds to treatment, if it responds at all, and how long patients who have had this treatment survive. Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The antibody is given as an infusion and finds its way to these cells. The radioactive iodine attached to the antibody delivers radiation directly to these cells which works to harm or kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this protein on the surface of their tumor cells. In addition, this protein was found on the surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma cells (less than 5%), these cells are resistant to chemotherapy and are believed to be responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be used after patients complete a course of chemotherapy and have residual myeloma cells left in their body. The Investigators are hoping that the treatment with Bexxar will decrease and possibly eliminate residual myeloma cells resistant to chemotherapy.
Study Details
Timeline
Interventions
The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 attached to Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from your body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated for you based on the scans performed following the dosimetric dose.