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Bexxar therapeutic 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Patients With an Objective Response

Secondary outcome measures

Duration of Response

Number of Participants With Complete Response (CR)

Progression Free Survival Time

+1 more

Side effects data

From 2013 Phase 3 trial • 14 Patients • NCT00268983

50%

Infusion related reaction

50%

Pyrexia

33%

Dizziness

33%

Headache

33%

Skin hypertrophy

33%

Flushing: Vascular

17%

Venous pressure jugular increased

17%

Leukopenia

17%

Dry eye

17%

Paraesthesia

17%

Lower respiratory tract infection

17%

Contusion

17%

Peripheral T-cell lymphoma unspecified

17%

Oedema

17%

Back pain

17%

Lymphopenia

17%

Rectal haemorrhage

17%

Toothache

17%

Oropharyngeal pain

17%

Oropharyngeal discomfort

17%

Breast mass

17%

Hypercalcaemia

17%

Pain in extremity

17%

Dry throat

17%

Hemorrhage

17%

Neutropenia

17%

Abdominal pain

17%

Anaemia

17%

Basal cell carcinoma

17%

Respiratory failure

17%

Sciatica

17%

Fatigue

17%

Pain

17%

Application site rash

17%

Asthenia

17%

Feeling cold

17%

Influenza like illness

17%

Arthralgia

17%

Myalgia

17%

Ligament disorder

17%

Musculoskeletal discomfort

17%

Musculoskeletal stiffness

17%

Constipation

17%

Nasal dryness

17%

Wheezing

17%

Rash erythematous

17%

Rash papular

17%

Nasopharyngitis

17%

Pelvic fracture

17%

Road traffic accident

17%

Euphoric mood

17%

Haemorrhage: Vascular

17%

Chills

17%

Feeling hot

17%

Hyperuricaemia

100%

80%

60%

40%

20%

Study treatment Arm

Rituximab 375 mg/m^2

TST/I-131 TST

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.

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Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,436 Total Patients Enrolled

47 Trials studying Multiple Myeloma

6,417 Patients Enrolled for Multiple Myeloma

University of Michigan Rogel Cancer CenterLead Sponsor

293 Previous Clinical Trials

24,081 Total Patients Enrolled

11 Trials studying Multiple Myeloma

498 Patients Enrolled for Multiple Myeloma

Mark Kaminski, MDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural instance of such a trial?

"Currently, only one live trial for Bexxar therapeutic is taking place in a single city and country. The initial experiment was commenced by GlaxoSmithKline in 2005 and included 16 patients who completed Phase 2 of the drug approval process. Since then, 22 additional studies have been finalized."

Answered by AI

What hazards should be considered when using Bexxar therapeutically?

"Currently, the perceived safety of Bexxar therapeutic is a two as it has only been subject to Phase 2 trials with evidence suggesting its safety yet lacking for efficacy."

Answered by AI

Has there been other research exploring the efficacy of Bexxar in a clinical setting?

"Currently, there is only one active clinical trial of Bexxar therapeutic in progress. This research has reached the third stage and it's taking place primarily at Ann Arbor, Michigan but also at an additional location."

Answered by AI

Are there still opportunities to enroll in this medical experiment?

"This clinical trial is no longer accepting new participants, the posting having been first made on August 1st 2005. The most recent edit was done on November 2nd 2022. For people looking for other studies, there are 807 trials actively recruiting individuals with multiple myeloma and a single medical research seeking patients to participate in Bexxar therapy."

Answered by AI

How many participants are being recruited for this research?

"At this time, the research team for this study is not taking on any new recruits. The trial was initially posted in August 2005 and last modified in November 2022. Nevertheless, a wealth of other opportunities exist; 807 clinical trials are currently welcoming people with multiple myeloma, while 1 Bexxar therapeutic trial is likewise recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2005. "Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00135200.

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