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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00642395
Eligibility Criteria:
Inclusion Criteria:
At time of diagnosis
* De novo multiple myeloma patients under 65 or in first relapse, in whom screening for chromosome 13 deletion and beta2microglobulin assay have been performed.
* Salmon and Durie Stage: III, II, I with symptomatic bone lesion (radiological)
* Patient's written informed consent
* No clinical signs of heart failure or coronary insufficiency with LVEF\>50%
* No hepatic in insufficiency: bilirubin\<35μmol/l and SGOT, SGPT, alkaline phosphatase less than 2.5 N
* No respiratory insufficiency: normal pulmonary function tests and DLCO\>50%
* No pre-existing renal impairment not related to the disease
* No history of any other malignant disease with the exception of basal cell carcinoma and stage I cervical cancer
* Negative HIV serology
* Effective contraception when justified
At the time of transplantation
* Good performance status (WHO score≤2)
* Creatinine≤170μmol/l and no ineligibility criteria for intensification
* Stem cells harvest ≥ 5x10E6 CD34/kg for 2 ASCT
* Absence of progressive disease before transplantation
Exclusion Criteria:
* Known refusal of the subject to participate to the study
* Female subject who is pregnant or breast-feeding
* History of allergy to any of the study medications, their analogues, or excipients in the various formulations
* Main liver insufficiency
* ≥ Grade 3 peripheral neuropathy on clinical examination within 14 days before enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00642395
Study Brief:
Protocol Section:
NCT00642395