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Stem Cell Transplant

Expanded Cord Blood Transplant for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Jean Roy, MD

Research Sponsored by Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65 years

Availability of a cord blood with specific HLA match and cell count requirements

Must not have

Having previously received autologous-allogeneic tandem transplantation

Poor organ function or specific cardiac, pulmonary, renal, or liver abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to expand cord blood cells that could improve outcomes for patients with multiple myeloma.

Who is the study for?

This trial is for adults aged 18-65 with newly diagnosed high-risk multiple myeloma who've had specific initial treatments and responded at least partially. They must have undergone a stem cell transplant using Melphalan, not received more than two transplants or certain maintenance drugs for long, and have a suitable cord blood match.

What is being tested?

The trial tests ECT-001 expanded cord blood transplant's safety and effectiveness in treating high-risk multiple myeloma patients. It aims to improve survival rates by potentially reducing chronic graft-versus-host disease and enhancing immune recovery compared to traditional methods.

What are the potential side effects?

While the ECT-001 expanded CB procedure has been safe in previous trials, potential side effects may include infection risks due to prolonged cytopenia (low blood cell counts), possible infusion reactions, and complications related to graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have a cord blood match that meets specific health standards.

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I have been newly diagnosed with multiple myeloma with specific genetic features.

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I have undergone a stem cell transplant after receiving high-dose Melphalan.

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I've had initial cancer treatment and my cancer partially responded.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had both autologous and allogeneic stem cell transplants.

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My heart, lungs, kidneys, or liver are not working well.

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My health severely limits my daily activities or I have several serious health issues.

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I have another cancer with a poor prognosis.

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I have been on Lenalidomide or Bortezomib for over 4 months after my stem cell transplant.

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I have undergone two autologous stem cell transplants.

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I might have a heart condition called cardiac amyloidosis.

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I do not have any uncontrolled or specific viral infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of ECT-001 expanded CB expansion

Incidence of chronic GVHD by grade at 1 years by NIH criteria.

Incidence of chronic GVHD by grade at 2 years by NIH criteria.

+3 more

Secondary study objectives

Best response achieve at 1 year after allogeneic transplant

Best response achieve at 2 year after allogeneic transplant

Correlation between neutrophil and CD34+ doses infused

+22 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ECT-001 (UM171) expanded cord bloodExperimental Treatment1 Intervention

1. Patients will receive a reduced intensity conditioning regimen containing Cyclophosphamide 50 mg/kg, Fludarabine 40 mg/m2 x 5 days and total body irradiation 200 cGy. 2. The cord to be expanded is thawed 7 days prior to transplant and undergoes CD34+ selection. The CD34+ product will be placed in the fed-batch culture with UM171 for a 7-day expansion and is infused fresh on Day 0. The CD34- product is cryopreserved and will be thawed and infused on Day +1. 3. Patients will receive standard supportive care and GVHD prophylaxis with Mycophenolate mofetil and Tacrolimus.

0 / 13Eligibility criteria met