Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 11:57 PM
Study NCT ID:
NCT01296204
Status:
COMPLETED
Last Update Posted:
2011-03-22
First Post:
2011-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131
Sponsor:
Centre René Gauducheau
Organization:
Study Overview
Official Title:
Phase I of Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BB4
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.
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Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: