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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
BB4 antibody-Iodine 131
Sponsored by
Centre René Gauducheau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre René Gauducheau
  • Moreau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BB4 antibody-Iodine 131

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 11, 2011
Last Updated
March 21, 2011
Sponsor
Centre René Gauducheau
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1. Study Identification

Unique Protocol Identification Number
NCT01296204
Brief Title
Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131
Acronym
BB4
Official Title
Phase I of Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre René Gauducheau

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. ÉcouterLire phonétiquement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (false)

8. Arms, Groups, and Interventions

Arm Title
BB4 antibody-Iodine 131
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BB4 antibody-Iodine 131
Intervention Description
Injection of an antibody after labelling with Iodine 131
Primary Outcome Measure Information:
Title
The dose limiting toxicities (DLT) will be analysed in order to determine the maximal tolerated dose (MTD) in a dose escalation study design.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Moreau
City
Nantes
Country
France

12. IPD Sharing Statement

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

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