Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborator: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Cadexomer iodine; Iodine; Iodine-131 anti-B1 antibody; Tositumomab I-131

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Expected survival ≥ 6 months

• Pre-study performance status of 0, 1, or 2 according to the World Health Organization (WHO)

• Newly diagnosed or relapsed/refractory myeloma with histologic confirmation of multiple myeloma by the Department of Pathology at University of Michigan Cancer Center (UMCC)

• Not more than 3 lines of therapy for myeloma for patients with relapsed disease

• Documented Stage II or III multiple myeloma (Durie and Salmon, 1975) prior to initiation of first line therapy

• At least 4 cycles of first line (for newly diagnosed patients) or salvage (for relapsed/refractory patients) prior therapy and in a plateau of at least partial response (Blade et al, 1999) for at least 2 determinations 6 weeks apart

• At least 21 days from day 1 of the last cycle and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy

• Measurable M-proteins with greater than 1 g/dl serum monoclonal protein and/or greater than 0.5 g/24 hour urine light chain excretion

• Acceptable hematologic status within two weeks prior to patient registration, including:

• Absolute neutrophil count ([segmented neutrophils + bands] x total white blood cell [WBC]) ≥ 1,500/mm3;

• Platelet counts ≥ 150,000/mm3; these patients will receive total body dose of 75 cGy of Bexxar; or

• Platelet counts from 100,000/mm3 to 149,000/mm3; these patients will receive a 65 cGy total body dose of Bexxar;

• In patients previously treated with ASCT, total body dose will be 55 cGy in patients with platelet count > 150,000 and 45 cGy in patients with platelets 100,000-149,000.

• Female patients who are not pregnant or lactating

• Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)

• Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for three or more weeks with no significant post treatment toxicities observed

• Patients determined to have < 25% bone marrow involvement with myeloma within six weeks of registration (based on bilateral core biopsy).

Exclusion Criteria:

• Patients with impaired bone marrow reserve, as indicated by one or more of the following:

• Platelet count < 100,000 cells/mm3;

• Hypocellular bone marrow;

• Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid);

• History of failed stem cell collection;

• Myelodysplastic syndrome (MDS) or evidence of other than myeloma clonogenic abnormalities;

• Prior radioimmunotherapy;

• Prior anti-CD20 therapy;

• Other than myeloma malignancy, except B-cell non-Hodgkin's lymphoma, basal and squamous cell carcinoma of the skin, and cervical and breast cancer in situ, unless patient is cancer free for > 3 years;

• Central nervous system (CNS) involvement;

• Patients with known HIV infection;

• Patients with pleural effusion;

• Patients with abnormal liver function: total bilirubin > 2.0 mg/dL;

• Patients with abnormal renal function: serum creatinine > 2.0 mg/dL;

• Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional);

• Patients who have received G-CSF or GM-CSF therapy within two weeks prior to treatment;

• Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives;

• Major surgery, other than diagnostic surgery, within four weeks;

• Presence of anti-murine antibody (HAMA) reactivity. This result must be available prior to receiving treatment for those patients with prior exposure to murine antibodies or proteins.