Multiple Myeloma Clinical Trial
Official title:
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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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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