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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT01460420
Eligibility Criteria:
Inclusion Criteria:
Phase I: For the first 10 patients:
* Patients with any haematological malignancy in \> CR1 (first complete remission)
* Suitable related donor human leukocyte antigen (HLA)identical
* Age \> 18 and \< 70 years
For the 10 subsequent patients:
* Patients with any haematological malignancy candidates to receive an allogeneic transplant
* Suitable related or unrelated donor (a maximum of 1 mismatched is allowed)
* Age \> 18 and \< 70 years phase II trial:
* High-risk multiple myeloma patients at first relapse / second complete remission candidates to receive an allogeneic transplantation
* Age:\> 18 \< 70 years.
* Suitable donor, related or unrelated (a maximum of 1 mismatched is allowed)
* Measurable disease
* High risk first relapse is defined as:
* First early relapse after Autologous Stem Cell Transplant (ASCT)\< 24 months
* First late relapses in case the patient does not achieve CR after second ASCT
* First relapse in patients with poor cytogenetic features
* All subjects must be able to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan.
Exclusion Criteria:
Any of the following:
* Prior severe comorbidity such as:
* Heart failure or previous infarction
* Uncontrolled Hypertension
* Arrhythmia
* Cirrhosis
* Peripheral neuropathy \>Grade 2, 14 days prior to inclusion
* Psychiatric disease
* Prior history of other neoplasia except for carcinoma in situ in the last 10 years
* Hypersensitivity to Bz, Boric acid mannitol.
* Patients unable to use appropriate contraceptive methods
* Patients who have received an investigational drug 30 days prior to inclusion
* Positive human immunodeficiency virus (HIV) or active viral hepatitis
* Patients with pericardial disease
* Patients with acute diffuse infiltrative pulmonary disease
* Patients not willing to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan
* Patients not willing to receive thromboprophylaxis during the consolidation phase will not be eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01460420
Study Brief:
Protocol Section:
NCT01460420