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

Centre René Gauducheau

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: BB4 antibody-Iodine 131

Study type

Interventional

Funder types

Other

Identifiers

NCT01296204

04/1B

Details and patient eligibility

About

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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Sex

All

Ages

18+ years old

Volunteers

No 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