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

NCT ID: NCT01296204

Last Updated: 2011-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL

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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Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BB4 antibody-Iodine 131

Group Type: EXPERIMENTAL

BB4 antibody-Iodine 131

Intervention Type: DRUG

Injection of an antibody after labelling with Iodine 131

Interventions

BB4 antibody-Iodine 131

Injection of an antibody after labelling with Iodine 131

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre René Gauducheau

OTHER

Sponsor Role: lead

Locations

Centre René Gauducheau

Nantes, , France

Moreau

Nantes, , France

Countries

France

Other Identifiers

04/1B

Identifier Type: -

Identifier Source: org_study_id