Multiple MyelomaPhase 2NCT00599495
Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT
A Phase 2 study testing allogeneic HSCT in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- allogeneic HSCT
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2002to Dec 2009
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support
- Age 18-60 years
- ECOG-performance status 0-1
- Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1)
Who cannot join
- Serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy
- Severe cardiac failure (ejection fraction < 40%)
- Severe impairment of renal function (Creatinine clearance < 50ml/min)
- Severe impairment of liver function (bilirubine > 2 fold of upper limits of normal)
- Pregnant or lactating women
- Other major organ or system dysfunctions(GI, neurological, psychiatric dysfunctions that would impair tolerance of chemotherapy or prolonged haematological recovery)
- Positivity for HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-study
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.
Read the detailed description
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.
- Conditions
- Multiple Myeloma
- Being tested
- allogeneic HSCT
- Keywords
- Hematopoietic Stem Cell Transplantation, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic HSCTProcedure or surgery
dose-reduced conditioning regimen
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment, chimerism, toxicity, non-relapse mortality
Measured: Follow-up until day +1095
Secondary outcomes (1)
Evaluation of response/GvHD/ infectious complications/ disease-free survival, Prognostic impact of cytogenetic, Evaluation of incidence and prognostic impact of molecular remission in patients with clinically complete remission.
Measured: Follow-up until day +1095
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startNov 2002
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaus Kroeger, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599495
- Sponsor's protocol ID
- EBMT MUDRIC-MM
- Status last verified
- Sep 2022
- First submitted
- 11 Jan 2008
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Kroger N, Shimoni A, Schilling G, Schwerdtfeger R, Bornhauser M, Nagler A, Zander AR, Heinzelmann M, Brand R, Gahrton G, Morris C, Niederwieser D, de Witte T. Unrelated stem cell transplantation after reduced intensity conditioning for patients with multiple myeloma relapsing after autologous transplantation. Br J Haematol. 2010 Jan;148(2):323-31. doi: 10.1111/j.1365-2141.2009.07984.x. Epub 2009 Nov 12.
PubMed 19912215
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-study
- ClinicalTrials.gov ID
- NCT00599495
- Acronym / sponsor ID
- EBMT MUDRIC-MM
- Conditions
- Multiple Myeloma
- Keywords
- Hematopoietic Stem Cell Transplantation, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jan 2008 (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 purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.
Detailed description
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support
- Age 18-60 years
- ECOG-performance status 0-1
- Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1)
Key exclusion criteria (7 listed)
- Serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy
- Severe cardiac failure (ejection fraction < 40%)
- Severe impairment of renal function (Creatinine clearance < 50ml/min)
- Severe impairment of liver function (bilirubine > 2 fold of upper limits of normal)
- Pregnant or lactating women
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 |
|---|---|---|
| allogeneic HSCTdose-reduced conditioning regimen | Procedure or surgery | – |
Primary outcome
Engraftment, chimerism, toxicity, non-relapse mortality
Time frame: Follow-up until day +1095
1 secondary outcome
Evaluation of response/GvHD/ infectious complications/ disease-free survival, Prognostic impact of cytogenetic, Evaluation of incidence and prognostic impact of molecular remission in patients with clinically complete remission.
Time frame: Follow-up until day +1095
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 2 Sep 2022.
- Results publication: PubMed 19912215Kroger N, Shimoni A, Schilling G, Schwerdtfeger R, Bornhauser M, Nagler A, Zander AR, Heinzelmann M, Brand R, Gahrton G, Morris C, Niederwieser D, de Witte T. Unrelated stem cell transplantation after reduced intensity conditioning for patients with multiple myeloma relapsing after autologous transplantation. Br J Haematol. 2010 Jan;148(2):323-31. doi: 10.1111/j.1365-2141.2009.07984.x. Epub 2009 Nov 12.
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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.
Nicolaus Kroeger, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allogeneic HSCT in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 7 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 2 Sep 2022. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Engraftment, chimerism, toxicity, non-relapse mortality (time frame: Follow-up until day +1095). 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 NCT00599495, which also lists 1 linked publication.
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 2 Sep 2022.