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NCT02270307 Clinical Trial

MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis

Multiple Myeloma Clinical Trial

— MSC-CY  

Official title:
Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells (MSC) as aGVHD Prophylaxis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02270307
Other study ID # MSC-CY-Russia
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received April 7, 2014
Last updated October 17, 2014
Start date January 2014
Est. completion date January 2016

Study information
Verified date October 2014
Source National Research Center for Hematology, Russia
Contact Elena N Parovichnikova, PhD,MD
Phone +79161252623
Email elenap@blood.ru
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial Summary

Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Description:

This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Refractory forms of acute leukemia, but in complete remission (CR)

- Second and third remission of acute leukemia

- 2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL)

- relapsed multiple myeloma

- advanced leukemia

Exclusion Criteria:

- ICU

- Mechanical ventilation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclophosphamide
Dose 50 mg/kg at day +3,+4 once daily
Biological:
• Mesenchymal stromal cells
Dose 1 million per kg, at day of recovery once

Locations
Country Name City State
Russian Federation BMT department Moscow

Sponsors (1)
Lead Sponsor Collaborator
National Research Center for Hematology, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 1 year No
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