Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT01296204
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01296204
Study Brief:
Protocol Section:
NCT01296204