Multiple MyelomaDMSOconc3NCT02452099
Impact of DMSO Concentrations on Hematopoietic Recovery After Autologous HSC Transplantation.
A study testing Cryopreservation of HSCs using 5% DMSO concentration, Cryopreservation of HSCs using 7,5% DMSO concentration and Cryopreservation of HSCs using 10% DMSO concentration in people with Multiple Myeloma and Lymphomas, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Lymphomas, Leukemias
- What is being tested?
- Cryopreservation of HSCs using 5% DMSO concentration, Cryopreservation of HSCs using 7,5% DMSO concentration and Cryopreservation of HSCs using 10% DMSO concentration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematological malignancies or solid tumors, refered for autologous HSC transplantation
- Written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site
MSC Memorial CAncer Center and Institute of Oncology
Gliwice, 44-101
About this study
Official title: Impact of Different DMSO Concentrations in Cryopreservation Mixture on Hematopoietic Recovery After Autologous Transplantation of Hematopoietic Stem Cells.
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.
Read the detailed 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.
- Conditions
- Multiple Myeloma, Lymphomas, Leukemias
- Being tested
- Cryopreservation of HSCs using 5% DMSO concentration, Cryopreservation of HSCs using 7,5% DMSO concentration, Cryopreservation of HSCs using 10% DMSO concentration
- Keywords
- DMSO, cryopreservation, autologous transplantation, hematopoietic stem cells, hematological malignancies
- Medical subject headings
- Multiple Myeloma, Lymphoma, Leukemia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreservation of HSCs using 5% DMSO concentrationProcedure or surgery
Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.
Cryopreservation of HSCs using 7,5% DMSO concentrationProcedure or surgery
Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.
Cryopreservation of HSCs using 10% DMSO concentrationProcedure or surgery
Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.
| Study group | Role | What they receive |
|---|---|---|
| 5% DMSO | Other | Not described Receives: Procedure: Cryopreservation of HSCs using 5% DMSO concentration |
| 7.5% DMSO | Other | Not described Receives: Procedure: Cryopreservation of HSCs using 7,5% DMSO concentration |
| 10% DMSO | Other | Not described Receives: Procedure: Cryopreservation of HSCs using 10% DMSO concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median time to neutrophils recovery after autoHSC transplantation.
Measured: The first from 3 consecutive days, on which absolute neutrophil count in peripheral blood will be higher than 0.5 G/L
Secondary outcomes (2)
The median time to platelets recovery after autoHSC transplantation.
Measured: 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.
Adverse reactions related with transplantation procedure
Measured: 24 hours after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Giebel, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452099
- Sponsor's protocol ID
- COI-DMSO-01
- Acronym
- DMSOconc3
- Status last verified
- Jan 2017
- First submitted
- 20 May 2015
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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 blood hematopoietic progenitor cells and engraftment after autologous transplantation. Vox Sang. 2015 May;108(4):417-24. doi: 10.1111/vox.12238. Epub 2015 Mar 6.
PubMed 25753814Mitrus 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% dimethyl sulfoxide if compared to 10% dimethyl sulfoxide containing medium. Cryobiology. 2013 Dec;67(3):327-31. doi: 10.1016/j.cryobiol.2013.09.167. Epub 2013 Oct 11.
PubMed 24125911Smagur 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 potential of cryopreserved peripheral blood hematopoietic stem and progenitor cells. Vox Sang. 2013 Apr;104(3):240-7. doi: 10.1111/j.1423-0410.2012.01657.x. Epub 2012 Oct 9.
PubMed 23046417
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different DMSO Concentrations in Cryopreservation Mixture on Hematopoietic Recovery After Autologous Transplantation of Hematopoietic Stem Cells.
- ClinicalTrials.gov ID
- NCT02452099
- Acronym / sponsor ID
- DMSOconc3 / COI-DMSO-01
- Conditions
- Multiple Myeloma, Lymphomas, Leukemias
- Keywords
- DMSO, cryopreservation, autologous transplantation, hematopoietic stem cells, hematological malignancies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5% DMSO | Other | Procedure: Cryopreservation of HSCs using 5% DMSO concentration |
| 7.5% DMSO | Other | Procedure: Cryopreservation of HSCs using 7,5% DMSO concentration |
| 10% DMSO | Other | Procedure: Cryopreservation of HSCs using 10% DMSO concentration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hematological malignancies or solid tumors, refered for autologous HSC transplantation
- Written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreservation of HSCs using 5% DMSO concentrationCryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration. | Procedure or surgery | 5% DMSO |
| Cryopreservation of HSCs using 7,5% DMSO concentrationCryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration. | Procedure or surgery | 7.5% DMSO |
| Cryopreservation of HSCs using 10% DMSO concentrationCryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration. | Procedure or surgery | 10% DMSO |
Primary outcome
The median time to neutrophils recovery after autoHSC transplantation.
Time frame: The first from 3 consecutive days, on which absolute neutrophil count in peripheral blood will be higher than 0.5 G/L
2 secondary outcomes
The median time to platelets recovery after autoHSC transplantation.
Time frame: 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.
Adverse reactions related with transplantation procedure
Time frame: 24 hours after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Results publication: PubMed 25753814Smagur 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 blood hematopoietic progenitor cells and engraftment after autologous transplantation. Vox Sang. 2015 May;108(4):417-24. doi: 10.1111/vox.12238. Epub 2015 Mar 6.
- Results publication: PubMed 24125911Mitrus 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% dimethyl sulfoxide if compared to 10% dimethyl sulfoxide containing medium. Cryobiology. 2013 Dec;67(3):327-31. doi: 10.1016/j.cryobiol.2013.09.167. Epub 2013 Oct 11.
- Results publication: PubMed 23046417Smagur 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 potential of cryopreserved peripheral blood hematopoietic stem and progenitor cells. Vox Sang. 2013 Apr;104(3):240-7. doi: 10.1111/j.1423-0410.2012.01657.x. Epub 2012 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryopreservation of HSCs using 5% DMSO concentration, Cryopreservation of HSCs using 7,5% DMSO concentration and Cryopreservation of HSCs using 10% DMSO concentration in people with Multiple Myeloma and Lymphomas, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median time to neutrophils recovery after autoHSC transplantation. (time frame: The first from 3 consecutive days, on which absolute neutrophil count in peripheral blood will be higher than 0.5 G/L). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452099, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.