NCT03441958CompletedPhase 1/2
ECT-001 (UM171) Expanded Cord Blood Transplant to Treat High-risk Multiple Myeloma
A Phase I-II Open-label Study of Reduced Intensity-allogeneic Transplant of ECT-001 (UM171/ Fed-batch Culture System) Expanded Cord Blood in Patients With High-risk Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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 potential curative treatment remains allogeneic Hematopoietic stem cell transplant (HSCT), as shown by our cohort of 92 newly diagnosed patients who received a sibling tandem auto-allo (HSCT) with an estimated 10-year progression free survival (PFS) of 43%. However, the high incidences of toxicities including chronic graft-versus-host-disease (GVHD) (up to 79%) and disease progression (up to 49%) impair improvement in cure rate. Using umbilical cord blood (CB) as an alternative source of hematopoietic stem cells (HSC) could be superior biologically because of their increased proliferative capacity, greater number of progeny with longer telomeres and better anti-tumor efficacy in presence of positive residual disease. Moreover, using CB has been shown to decrease incidence of chronic GVHD. However, CBs have the disadvantage of having a limited HSC dose leading to prolonged cytopenia and higher risk of infections. In a first in-human trial using CB expanded with the ECT-001 (UM171) molecule (clinicaltrial.gov # NCT02668315), the median net expansion of HSC was 36 fold, which allows for the selection of better HLA matched CB regardless of their lower HSC dose. Moreover, the ECT-001 expanded CBs have a different cell composition than regular CBs, with more than 25% of dendritic cell precursors. This, combined to better HLA matched CBs, may reduce chronic GVHD incidence and improve immune reconstitution. To date, 22 patients received an ECT-001 expanded CB and the procedure proved to be safe and feasible. In this new trial, the goal is to evaluate the safety and efficacy of ECT-001 expanded CB transplant in high risk MM patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 2 Feb 2018
- Start date
- 7 Mar 2018
- Primary completion date
- 28 Oct 2023
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Diseases
- Multiple myeloma
- NCT number
- NCT03441958
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 19
- From 7 Mar 2018 to the primary completion date, 28 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve Rosemond Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.