ECT-001 (UM171) Expanded Cord Blood Transplant to Treat High-risk Multiple Myeloma

Korábbi kezelés

• Having previously received two ASCT.
• Having previously received autologous-allogeneic tandem transplantation.
• Having received more than 4 months of maintenance with Lenalidomide or Bortezomib after ASCT.
• Participation in a trial with an investigational agent within 30 days prior to entry in the study.

Más betegség

• Uncontrolled infection.
• Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B or C.
• Presence of another malignancy with an expected survival estimated \< 75% at 5 years.
• Suspicion of cardiac amyloidosis.
• Current history of drug and/or alcohol abuse.

Laborértékek

• 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.
• 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.
• Non secretory disease or non-measurable disease in serum or urine at time of diagnosis.
• Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient's condition or study outcome.

Egyéb

• Karnofsky score \< 70% or comorbidity index HCT-CI \> 3.
• Availability of a matched sibling donor.
• Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
• Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.

• Age 18-65 years.
• Newly diagnosed multiple myeloma using the International Myeloma Working Group criteria with measurable disease and any of the following:
  • 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
• 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.
• Received high-dose Melphalan ≥ 140 mg/m2 followed by ASCT.
• 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.