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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03441958
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65 years.
2. Newly diagnosed multiple myeloma using the International Myeloma Working Group criteria with measurable disease and any of the following:
i. t(4;14), t(14;16), t(14;20), del(17p13), chromosome 1 abnormalities with ISS II or III; ii. Revised-ISS 3; iii. Primary plasma cell leukemia; iv. Refractory to first line triplet Bortezomib-based induction treatment. v. ≥ 2 cytogenetics abnormalities as defined above regardless of ISS stage
3. Received a first line triplet Bortezomib-induction regimen for a minimum of 4 cycles with achievement of at least partial response; or received a doublet or triplet Lenalidomide-based second line induction treatment with at least partial response for patients refractory to Bortezomib in first line.
4. Received high-dose Melphalan ≥ 140 mg/m2 followed by ASCT.
5. Availability of a cord blood with an HLA match ≥ 5/8 and \< 8/8 meeting the following requirements: CD34+ cell count ≥ 0.5 x 105/kg and nucleated cell count \>= 1.5 x 107/kg.
Exclusion Criteria:
1. Having previously received two ASCT.
2. Having previously received autologous-allogeneic tandem transplantation.
3. Having received more than 4 months of maintenance with Lenalidomide or Bortezomib after ASCT.
4. Poor organ function defined as either: forced vital capacity, forced expiratory volume in 1 second or lung diffusing capacity of carbon monoxide corrected for hemoglobin \< 50%, left ventricular ejection fraction \< 40% (evaluated by either echocardiogram or MUGA), uncontrolled arrhythmia or symptomatic cardiac disease, creatinine clearance \< 60 mL/minute.
5. Karnofsky score \< 70% or comorbidity index HCT-CI \> 3.
6. Bilirubin \> 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis; AST and ALT \> 2.5 x ULN; alkaline phosphatase \> 5 x ULN; liver cirrhosis.
7. Non secretory disease or non-measurable disease in serum or urine at time of diagnosis.
8. Uncontrolled infection.
9. Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B or C.
10. Presence of another malignancy with an expected survival estimated \< 75% at 5 years.
11. Suspicion of cardiac amyloidosis.
12. Current history of drug and/or alcohol abuse.
13. Availability of a matched sibling donor.
14. Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
15. Participation in a trial with an investigational agent within 30 days prior to entry in the study.
16. Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
17. Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient's condition or study outcome.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03441958
Study Brief:
Protocol Section:
NCT03441958