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

Multiple Myeloma Clinical Trial

— BB4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296204
• Other study ID #: 04/1B
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2011
• Last updated: March 21, 2011

Study information

• Verified date: February 2011
• Source: Centre René Gauducheau
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Afssaps
• Study type: Interventional

Clinical Trial 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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• BB4 antibody-Iodine 131
Injection of an antibody after labelling with Iodine 131

Locations

Country	Name	City	State
France	Centre René Gauducheau	Nantes
France	Moreau	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre René Gauducheau

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose limiting toxicities (DLT) will be analysed in order to determine the maximal tolerated dose (MTD) in a dose escalation study design.			Yes