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:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03832127
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation.
* Patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to ESMO's European recommendations
* MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).
* Patient affiliated with a social insurance scheme
* The patient must understand and voluntarily sign the informed consent form
* Women of childbearing potential must have a serum pregnancy test (performed within 2 days before each PET scan.)
* Women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last PET.
* Male patients (vasectomised or not) with a pregnant partner or a partner of childbearing potential must use a condom and a spermicide until 90 days after the last PET.
* HIV serology known to be negative
* Karnofsky ≥ 70 or ECOG 0-1
Exclusion Criteria:
* Age under 18 years
* Pregnancy or breastfeeding
* Male or female refusing birth control conditions
* Primary AL amyloidosis and myeloma complicated by amyloidosis
* Neutropenia \<1000 PN / mm3
* Thrombocytopenia \<70,000 / mm3
* Hepatic impairment: bilirubin\> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N
* Renal impairment defined by creatinine clearance \<50 ml / min
* History of other malignancies with the exception of basal cell carcinoma and stage I cervical cancer
* Severe active infection
* Active infection with known hepatitis B or C virus.
* Patient with insulin-dependent or non-insulin-dependent diabetes mellitus.
* Intolerance or known allergy to any of the study drugs or any of its analogues
* Psychiatric illness that may interfere with participation in the study
* Patient under safeguard of justice
* Intellectual inability to sign informed consent
* Persons protected by law
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03832127
Study Brief:
Protocol Section:
NCT03832127