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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03319667
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria :
* Multiple myeloma (IMWG criteria).
* Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants \< 65 years with comorbidities impacting possibility of transplant.
* Evidence of measurable disease.
* Written informed consent.
Exclusion criteria:
* Age \< 18 years.
* Prior treatment for multiple myeloma.
* Any other prior or ongoing disease/health conditions incompatible with the study objectives.
* Organ function values not met.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) \> 2.
* Hypersensitivity to the study medications.
* Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
* Male participants who disagree to follow the study contraceptive counseling.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03319667
Study Brief:
Protocol Section:
NCT03319667