Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131 (BB4)

March 21, 2011 updated by: Centre René Gauducheau

Phase I of Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131

The first step of this protocol called step pre-treatment study the biodistribution and pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing doses of iodine 131. At least 17 patients will be included for an estimated duration of 2 years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side effects, medium and long terms will be analyzed. After determining the toxic dose limit, patients will be treated at the maximum tolerated dose, for a total of 15 patients at this level, which will measure the objective tumor response to treatment. These patients will be followed for 1 year after injection therapy.

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Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44805
        • Centre René Gauducheau
      • Nantes, France
        • Moreau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a confirmed diagnosis of multiple myeloma (> 10% plasma cells on a previous myelogram)
  • Secretion of a monoclonal immunoglobulin
  • No myelodysplasia evaluated by myelogram
  • Disease refractory or relapsed after at least 3 lines of therapy
  • Patients with a dated and signed the consent form
  • Collection of autologous peripheral blood stem cells containing at least 2. 106 CD 34 + cells / kg
  • Age> 18 years
  • Performance status <2 (see Annex I), life expectancy of more than 3 months
  • No chemotherapy or radiotherapy within 4 weeks before inclusion
  • No major surgery within 4 weeks preceding the assessment of inclusion
  • No bisphosphonates within 2 weeks prior radioimmunotherapy, except for treatment started more than three months ago.
  • Normality of the biological assessment:
  • Creatinine less than or equal to 1.5 times the normal laboratory
  • Liver: less than or equal to 1.5 times the normal laboratory (free and conjugated bilirubin, SGOT, SGPT, gamma GT PAL)
  • Hemoglobin ≥ 8 g/mm3
  • ≥ 3 WBC 000/mm3
  • Neutrophils ≥ 1 500/mm3
  • Platelets ≥ 100 000/mm3

Exclusion Criteria:

Patients with other cancers except uterine carcinoma in situ or basal cell skin carcinoma

  • Patients with other (s) condition (s) Severe (s) to prevent tolerance to study and conduct the study to completion
  • Patient is pregnant or unwilling to take a contraceptive treatment for three months after treatment
  • Collection of peripheral blood stem cells containing less than 2106 CD 34 + cells / kg
  • Patients enrolled in another experimental treatment protocol
  • Patients who already received treatment with radioimmunotherapy
  • Myelodysplasia assessed by myelogram
  • Patient with thyroid
  • Patient unable to sign informed consent ÉcouterLire phonétiquement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BB4 antibody-Iodine 131
Drug: BB4 antibody-Iodine 131
Injection of an antibody after labelling with Iodine 131

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The dose limiting toxicities (DLT) will be analysed in order to determine the maximal tolerated dose (MTD) in a dose escalation study design.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre René Gauducheau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2011

Last Update Submitted That Met QC Criteria

March 21, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/1B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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