Impact of DMSO Concentrations on Hematopoietic Recovery After Autologous HSC Transplantation.

Multiple Myeloma Clinical Trial

— DMSOconc3  

Official title:

Impact of Different DMSO Concentrations in Cryopreservation Mixture on Hematopoietic Recovery After Autologous Transplantation of Hematopoietic Stem Cells.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452099
• Other study ID #: COI-DMSO-01
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: January 17, 2017
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of the study was to evaluate the clinical impact of different DMSO concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of hematopoiesis after autologous hematopoietic stem cell transplantation.

Description:

The procedure of autologous hematopoietic stem cell (HSC) transplantation requires cryopreservation of HSCs. Addition of DMSO (dimethyl sulfoxide) is necessary to secure the viability of such cells, but this cryoprotectant is potentially toxic to stem cell recipient. The concentrations of DMSO in cryopreservation mixture vary strongly between protocols in different transplant centers. Usually, the HSCs are stored in mixtures containing 10% DMSO, but there is no sufficient evidence that this concentration of DMSO is indeed optimal.

The main aim of the study is to evaluate the clinical impact of reduction of DMSO concentration in cryopreservation mixture on engraftment after autologous hematopoietic stem cell transplantation. 150 consecutive patients will be randomly assigned to one of three study arms (50 patients each). HSCs obtained by leukapheresis will be cryopreserved in three concentrations of DMSO: 5%, 7.5%, 10%, respectively. Evaluation of the mixtures will be carried out by monitoring reconstitution of hematopoiesis and the frequency the side effects in patients. The most important aspect of our evaluation will be the speed of neutrophil recovery after transplantation (defined by the first day, when absolute neutrophil count in peripheral blood will be higher than 0.5 G/L). The investigators will also evaluate the toxicity of cell suspension by monitoring the frequency of infusion-related adverse events (like nausea or vomiting) during infusion and 24 hours after transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hematological malignancies or solid tumors, refered for autologous HSC transplantation

• Written informed consent

Related Conditions & MeSH terms

• Leukemias
• Lymphomas
• Multiple Myeloma

Intervention

Procedure:
• Cryopreservation of HSCs using 5% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.
• Cryopreservation of HSCs using 7,5% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.
• Cryopreservation of HSCs using 10% DMSO concentration
Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.

Locations

Country	Name	City	State
Poland	MSC Memorial CAncer Center and Institute of Oncology	Gliwice

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Mitrus I, Smagur A, Giebel S, Gliwinska J, Prokop M, Glowala-Kosinska M, Chwieduk A, Sadus-Wojciechowska M, Tukiendorf A, Holowiecki J. A faster reconstitution of hematopoiesis after autologous transplantation of hematopoietic cells cryopreserved in 7.5% — View Citation

Smagur A, Mitrus I, Ciomber A, Panczyniak K, Fidyk W, Sadus-Wojciechowska M, Holowiecki J, Giebel S. Comparison of the cryoprotective solutions based on human albumin vs. autologous plasma: its effect on cell recovery, clonogenic potential of peripheral b — View Citation

Smagur A, Mitrus I, Giebel S, Sadus-Wojciechowska M, Najda J, Kruzel T, Czerw T, Gliwinska J, Prokop M, Glowala-Kosinska M, Chwieduk A, Holowiecki J. Impact of different dimethyl sulphoxide concentrations on cell recovery, viability and clonogenic potenti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The median time to neutrophils recovery after autoHSC transplantation.		The first from 3 consecutive days, on which absolute neutrophil count in peripheral blood will be higher than 0.5 G/L
Secondary	The median time to platelets recovery after autoHSC transplantation.		The first from 3 consecutive days, on which platelet count in peripheral blood will be higher than 20 G/L, without platelet transfusion 7 days prior.
Secondary	Adverse reactions related with transplantation procedure		24 hours after transplantation