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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The dose limiting toxicities (DLT) will be analysed in order to determine the maximal tolerated dose (MTD) in a dose escalation study design.

Safety Issue:

Yes

Authority:

France : Afssaps

Study ID:

04/1B

NCT ID:

NCT01296204

Start Date:

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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