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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT01421927
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 65 years
* Multiple Myeloma in 2nd or 3rd complete or partial response\*
* Disease never refractory to lenalidomide
* Lenalidomide treatment ≤ 9 months
* HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level)
* Insured under Social Security
* Information and consent signed
Exclusion Criteria:
* Stable or progressive disease
* Hypersensitivity to lenalidomide or excipients
* Lenalidomide treatment \> 9 months
* Absence of efficient contraception in women or men
* Cardiac insufficiency (ejection fraction \< 50% by echocardiography)
* Pulmonary disease characterized by DLCO \< 60%
* Severe renal insufficiency (clearance of creatinin \< 30 ml/min)
* Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin \> 2 times the upper normal value except in case of Gilbert's disease
* Bacterial, Viral or Fungal uncontrolled infections
* No contraceptive method for Female subjects of childbearing potential
* No use of condoms for males subjects
* Pregnant or breast feeding woman
* History of previous cancer (other than myeloma) except if the patient is in complete remission for more than 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01421927
Study Brief:
Protocol Section:
NCT01421927