← Back to Search

Stem Cell Transplant

Expanded Cord Blood Transplant for Multiple Myeloma

Q: What objectives is this clinical trial hoping to fulfill?

<p>Over the course of 5 years, researchers aim to assess <a href="https://www.withpower.com/clinical-trials/ect">ECT</a>-001 expanded CB's feasibility for <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a>. Secondary objectives include measuring overall survival via Kaplan Meier analysis, conducting a pharmaco-economic evaluation of proposed treatments compared to traditional chemotherapy and evaluating best response two year post transplantation.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 65 years old.

Select...

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

Select...

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

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

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. 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. Patients will receive standard supportive care and GVHD prophylaxis with Mycophenolate mofetil and Tacrolimus.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre C3iUNKNOWN

Ciusss de L'Est de l'Île de MontréalLead Sponsor

70 Previous Clinical Trials

5,540 Total Patients Enrolled

2 Trials studying Multiple Myeloma

30 Patients Enrolled for Multiple Myeloma

ExCellThera inc.Industry Sponsor

4 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

ECT-001 (UM171) expanded cord blood (Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT03441958 — Phase 1 & 2

Multiple Myeloma Research Study Groups: ECT-001 (UM171) expanded cord blood

Multiple Myeloma Clinical Trial 2023: ECT-001 (UM171) expanded cord blood Highlights & Side Effects. Trial Name: NCT03441958 — Phase 1 & 2

ECT-001 (UM171) expanded cord blood (Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03441958 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study admit those who are octogenarians?

"This clinical trial is open to adult patients aged between 18 and 65."

Answered by AI

Is recruitment currently open for this clinical endeavor?

"On clinicaltrials.gov, this medical trial is indicated to be no longer recruiting participants. Initially posted on March 7th 2018 and last edited on the 8th of March 2022, it appears that additional patients are not being sought for this specific study; however, there are presently 807 other trials open for potential enrolment."

Answered by AI

Am I eligible to participate in this medical experiment?

"This medical study requires 20 participants between 18 and 65 years of age that have multiple myeloma. Additionally, they must satisfy the stipulations which demand completion of a minimum 4-cycle Bortezomib triplet induction regimen with at least partial response or alternatively accept Lenalidomide doublet/triplet second line induction treatment for those refractory to initial Bortezomib therapy also achieving partial response."

Answered by AI

What objectives is this clinical trial hoping to fulfill?

"Over the course of 5 years, researchers aim to assess ECT-001 expanded CB's feasibility for multiple myeloma. Secondary objectives include measuring overall survival via Kaplan Meier analysis, conducting a pharmaco-economic evaluation of proposed treatments compared to traditional chemotherapy and evaluating best response two year post transplantation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jean Roy 2018. "ECT-001 (UM171) Expanded Cord Blood Transplant to Treat High-risk Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03441958.

All > Multiple Myeloma