Multiple MyelomaPhase 2NCT00781170
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
A Phase 2 study testing allogeneic hematopoietic SCT in people with Multiple Myeloma and Stem Cell Transplantation, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Multiple Myeloma, Stem Cell Transplantation
- What is being tested?
- allogeneic hematopoietic SCT
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2000to not given
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Myeloma Stadium II / III acc. to Salmon and Durie
- signed informed consent
- adequate organ function prior autologous respectively allogeneic SCT
- availability of HLA-identical related or unrelated donor
- availability of at least 2 x 10^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10^6 CD34+ cells for allogeneic SCT
- for MRD-SCT: 18-66 years; for MUD-SCT: 18-55 years
- at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky
- consent of donor to give DLI
Who cannot join
- severe heart insufficiency
- cardiovascular diseases or severe concomitant diseases
- active infections that need antibiotic therapy
- positive for HIV or hepatitis
- malign secondary disease
- limited liver function with total bilirubin > 1.5 ULN
Show all 11Show fewer
- increased transaminase > 3 ULN
- increased serum creatinine > 2 mg/dl
- pregnant or lactating women
- known hypersensitivity to Fludarabine or Melphalan
- participation in another trial
About this study
Official title: Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III
To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.
- Conditions
- Multiple Myeloma, Stem Cell Transplantation
- Being tested
- allogeneic hematopoietic SCT
- Keywords
- Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation
- Medical subject headings
- Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic hematopoietic SCTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.
Secondary outcomes (5)
Evaluation of engraftment of leucocytes and platelets
Evaluation of incidence of acute and chronic GvHD
Evaluation of infectious complications
Evaluation of the effects of DLI in case of no CR
Evaluation of disease-free and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startMay 2000
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Investigators
- Nicolaus Kroeger, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781170
- Sponsor's protocol ID
- Auto/Allo Plasmozytom
- Status last verified
- May 2009
- First submitted
- 22 Oct 2008
- Last updated
- 28 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kroger N, Badbaran A, Zabelina T, Ayuk F, Wolschke C, Alchalby H, Klyuchnikov E, Atanackovic D, Schilling G, Hansen T, Schwarz S, Heinzelmann M, Zeschke S, Bacher U, Stubig T, Fehse B, Zander AR. Impact of high-risk cytogenetics and achievement of molecular remission on long-term freedom from disease after autologous-allogeneic tandem transplantation in patients with multiple myeloma. Biol Blood Marrow Transplant. 2013 Mar;19(3):398-404. doi: 10.1016/j.bbmt.2012.10.008. Epub 2012 Oct 16.
PubMed 23078786
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III
- ClinicalTrials.gov ID
- NCT00781170
- Acronym / sponsor ID
- Auto/Allo Plasmozytom
- Conditions
- Multiple Myeloma, Stem Cell Transplantation
- Keywords
- Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2000
- First posted
- 28 Oct 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.
To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Multiple Myeloma Stadium II / III acc. to Salmon and Durie
- signed informed consent
- adequate organ function prior autologous respectively allogeneic SCT
- availability of HLA-identical related or unrelated donor
- availability of at least 2 x 10^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10^6 CD34+ cells for allogeneic SCT
Key exclusion criteria (11 listed)
- severe heart insufficiency
- cardiovascular diseases or severe concomitant diseases
- active infections that need antibiotic therapy
- positive for HIV or hepatitis
- malign secondary disease
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 hematopoietic SCT | Procedure or surgery | – |
Primary outcome
Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.
5 secondary outcomes
Evaluation of engraftment of leucocytes and platelets
Evaluation of incidence of acute and chronic GvHD
Evaluation of infectious complications
Evaluation of the effects of DLI in case of no CR
Evaluation of disease-free and overall survival
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 28 May 2009.
- Derived from this study: PubMed 23078786Kroger N, Badbaran A, Zabelina T, Ayuk F, Wolschke C, Alchalby H, Klyuchnikov E, Atanackovic D, Schilling G, Hansen T, Schwarz S, Heinzelmann M, Zeschke S, Bacher U, Stubig T, Fehse B, Zander AR. Impact of high-risk cytogenetics and achievement of molecular remission on long-term freedom from disease after autologous-allogeneic tandem transplantation in patients with multiple myeloma. Biol Blood Marrow Transplant. 2013 Mar;19(3):398-404. doi: 10.1016/j.bbmt.2012.10.008. Epub 2012 Oct 16.
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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
University Medical Center Hamburg-Eppendorf, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allogeneic hematopoietic SCT in people with Multiple Myeloma and Stem Cell Transplantation, run by Universitätsklinikum Hamburg-Eppendorf.
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 8 inclusion and 11 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 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.. 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 NCT00781170, 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 28 May 2009.