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

NCT00135200 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2005.035IRB # 2005-0403 and HUM 43767
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With an Objective Response

  The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level. An objective response may be: Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations. Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations. Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation.

  3 months

Secondary Outcomes (4)

• Number of Participants With Complete Response (CR)

  6 months

• Duration of Response

  up to approximately 15 years after treatment

• Progression Free Survival Time

  up to approximately 15 years after treatment

• Time to Treatment Failure

  up to approximately 15 years after treatment

Study Arms (1)

Bexxar therapeutic

EXPERIMENTAL

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 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's 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 based on the scans performed following the dosimetric dose.

Drug: Iodine I 131 Tositumomab

Interventions

Iodine I 131 Tositumomab DRUG

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.

Also known as: Bexxar

Bexxar therapeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tositumomab I-131

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Mark Kaminski, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

mkaminsk@umich.edu

(734) 936-5310

Study Officials

• Mark Kaminski, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 25, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2013
• Study Completion: September 4, 2024
• Last Updated: April 30, 2025
• Results First Posted: November 20, 2014

Record last verified: 2025-04

Locations

US (1)