← Back to Search

Radioactive Antibody Treatment for Multiple Myeloma

Phase 2

Waitlist Available

Led By Mark Kaminski, MD

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 15 years after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with newly diagnosed or relapsed multiple myeloma who will receive consolidation treatment with Bexxar, a radioactive antibody. The study will look at how patients respond to the treatment and what side effects occur.

Who is the study for?

This trial is for adults over 18 with newly diagnosed or relapsed multiple myeloma, who have undergone at least 4 cycles of therapy and are showing a partial response. They should not have had more than three prior treatments if relapsed, and must have measurable levels of certain proteins indicating myeloma.

What is being tested?

The study tests Bexxar®, a radioactive antibody targeting CD20 protein on cancer cells, as consolidation treatment post-chemotherapy in multiple myeloma patients. It aims to reduce or eliminate resistant cancer cells by delivering radiation directly to them.

What are the potential side effects?

Potential side effects include reactions related to the infusion of the antibody, radiation exposure risks such as damage to nearby healthy tissue, fatigue, lowered blood cell counts increasing infection risk, and possible thyroid issues due to iodine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 15 years after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 15 years after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 15 years after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Patients With an Objective Response

Secondary study objectives

Duration of Response

Number of Participants With Complete Response (CR)

Progression Free Survival Time

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bexxar therapeuticExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out