Status:
ACTIVE_NOT_RECRUITING
ECT-001 (UM171) Expanded Cord Blood Transplant to Treat High-risk Multiple Myeloma
Lead Sponsor:
Ciusss de L'Est de l'Île de Montréal
Collaborating Sponsors:
ExCellThera inc.
Centre C3i
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Multiple Myeloma (MM) is a morbid disease associated with a poor outcome and while current therapies with new drugs have improved survival, MM still remains incurable in most patients. The only potent...
Detailed Description
This is a single institution, prospective, phase I/II open-label study in a maximum of 20 patients evaluating a novel treatment strategy in NDMM patients with high-risk disease who do not have a 6/6 c...
Eligibility Criteria
Inclusion
- Age 18-65 years.
- 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
- 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.
Exclusion
- 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.
- 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.
- Karnofsky score \< 70% or comorbidity index HCT-CI \> 3.
- 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.
- 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.
- Availability of a matched sibling donor.
- Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
- Participation in a trial with an investigational agent within 30 days prior to entry in the study.
- Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient's condition or study outcome.
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 17 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03441958
Start Date
March 7 2018
End Date
October 17 2025
Last Update
February 8 2024
Active Locations (1)
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1
CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve Rosemond
Montreal, Quebec, Canada, H1T2M4