Multiple MyelomaMM-FISH/DNANCT00639054
The Molecular Characterization of Multiple Myeloma at Relapse
An observational study of Multiple Myeloma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Observational study investigating prognostic factors in newly diagnosed and relapsed multiple myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic markers and gene expression profiling (myeloma cells from fresh bone marrow samples). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bone marrow examination and Blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Dec 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed and/or treated at departments of hematology. Healthy controls.
Who may be able to join
- patients newly diagnosed with multiple myeloma and at the same time eligible for high dose chemotherapy and autologous stem cell transplantation
- patients with multiple myeloma experiencing relapse after high dose chemotherapy and autologous stem cell transplantation
Who cannot join
- for newly diagnosed patients: age or comorbidity preventing high dose chemotherapy and autologous stem cell transplantation,
- for all patients: age below 18, physical or psychological incapability to give an informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Multiple Myeloma Research Laboratory, Dept Hematology, Cph Univ Hosp Rigshospitalet
Copenhagen, Capital Region, DK-2100
About this study
Observational study investigating prognostic factors in newly diagnosed and relapsed multiple myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic markers and gene expression profiling (myeloma cells from fresh bone marrow samples). Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood samples.
Read the detailed description
Multiple myeloma (MM) is an incurable cancer. The disease can often be brought to a halt with chemotherapy which in younger patients is accompanied by stem cell transplantation. But the disease relapses almost invariably. Cytogenetic changes in the myeloma cells can serve as prognostic markers. Accordingly, 25% of the patients show changes associated with a prognosis so poor that they should probably receive experimental treatment right from the start. Nevertheless, a part of these patients survive much longer than expected. Thus, the prognosis must depend on additional genetic events.
The aim of this project is to widen the investigators knowledge of the nature, chronology and prognostic value of the genetic events in MM in order to improve the risk stratification of the patients and hence the choice of treatment. Using cytogenetics (interphase FISH) and molecular biological analyses (SNP, GEP, miRNA) the investigators will study the changes in the myeloma cells. The investigators will search for genetic and clinical differences between patients within the same cytogenetic group and between patients at diagnosis and at relapse. The study population will consist of 100 newly diagnosed patients and 100 relapse patients included prospectively over a 2-year period in a cooperation between the four departments of hematology in Zealand, Denmark.
Hypotheses:
- Early relapse depends on a) molecular defects in the myeloma cells detectable with FISH, GEP, SNP and/or miRNA analyses, and b) the acquisition of new mutations resulting in chemotherapy resistance and increased prolific capacity.
- The progressive reduction of event free survival seen with every relapse until the disease turns refractory can be explained by selection of critical mutations.
- The cytogenetic changes associated with poor prognosis represent a heterogenous group of patients in whom the responsible genetic events remain unknown.
- Conditions
- Multiple Myeloma
- Being tested
- Bone marrow examination, Blood samples
- Keywords
- classification, diagnosis, genetics, mortality, pathology
- Medical subject headings
- Multiple Myeloma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow examinationProcedure or surgery
7.5 ml of iliac crest bone marrow drawn in addition to diagnostic samples.
Blood samplesProcedure or surgery
24 ml of cubital vein blood drawn in addition to diagnostic samples.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed patients | Newly diagnosed high-dose therapy candidates. Participation means bone marrow examination (donating 7.5 ml of fresh bone marrow) and blood samples (24 ml of peripheral blood) for biochemical and genetic analyses regarding multiple myeloma, and granting access to clinical data relating to multiple myeloma. Receives: Procedure: Bone marrow examination; Procedure: Blood samples | |
| Relapse patients | Formerly high-dose treated patients with progressive disease. Participation means bone marrow examination (donating 7.5 ml of fresh bone marrow) and blood samples (24 ml of peripheral blood) for biochemical and genetic analyses regarding multiple myeloma, and granting access to clinical data relating to multiple myeloma. Receives: Procedure: Bone marrow examination; Procedure: Blood samples | |
| Healthy controls | Healthy blood and bone marrow donors. Participation means bone marrow examination (donating 7.5 ml of fresh bone marrow) for genetic analyses serving to compare normal bone marrow with bone marrow from multiple myeloma patients. Receives: Procedure: Bone marrow examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular characteristics (by FISH, SNP, GEP, miRNA)
Measured: 0-3 years
Secondary outcomes (2)
Event free survival (EFS)
Measured: 0-10 years
Overall survival (OS)
Measured: 0-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2014
- Study completionDec 2014
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 Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Zealand University Hospital, Naestved Hospital, Agnes og Poul Friis Fond, Carl og Ellen Hertzs Legat til Dansk Læge- og Naturvidenskab, Dagmar Marshalls Fond, Danish Cancer Research Foundation, Direktør Jacob Madsen og hustru Olga Madsens Fond, Elna og Jørgen Fagerholt Pedersens Kræftforskningsfond, Eva og Henry Frænkels Mindefond, Manufacturer Einar Willumsen's memorial team, Fonden til Lægevidenskabens Fremme, Grosserer M. Brogaard og Hustrus Mindefond, Højmosegård-Legatet, Janssen-Cilag, S.A., Karen A. Tolstrups fond, Krista og Viggo Petersens Fond, Købmand Sven Hansen og hustru Ina Hansens Fond, Meta og Håkon Baggers Fond, Reinholdt W. Jorck og hustrus Fond
- Responsible party
- Principal investigator, N. Emil U. Hermansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- N Emil U Hermansen, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletPeter Gimsing, MD, DMSc, Study chair, Copenhagen University Hospital, RigshospitaletAnnette J Vangsted, MD, DMSc, Study chair, Zealand University HospitalMette K Andersen, MD, DMSc, Study chair, Copenhagen University Hospital, RigshospitaletFinn C Nielsen, MD, DMSc, Study chair, Copenhagen University Hospital, RigshospitaletDan Kristensen, MD, Study chair, Naestved Hospital, DenmarkNielsaage T Clausen, MD, Study chair, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639054
- Sponsor's protocol ID
- 959593931/Emil Hermansen
- Other IDs
- H-B-2007-117
- Acronym
- MM-FISH/DNA
- Status last verified
- Jan 2016
- First submitted
- 11 Mar 2008
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermansen NE, Borup R, Andersen MK, Vangsted AJ, Clausen NT, Kristensen DL, Nielsen FC, Gimsing P. Gene expression risk signatures maintain prognostic power in multiple myeloma despite microarray probe set translation. Int J Lab Hematol. 2016 Jun;38(3):298-307. doi: 10.1111/ijlh.12486. Epub 2016 Mar 29.
PubMed 27027250
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular Characterization of Multiple Myeloma at Relapse
- ClinicalTrials.gov ID
- NCT00639054
- Acronym / sponsor ID
- MM-FISH/DNA / 959593931/Emil Hermansen
- Conditions
- Multiple Myeloma
- Keywords
- classification, diagnosis, genetics, mortality, pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev Hospital, Zealand University Hospital, Naestved Hospital, Agnes og Poul Friis Fond, Carl og Ellen Hertzs Legat til Dansk Læge- og Naturvidenskab, Dagmar Marshalls Fond, Danish Cancer Research Foundation, Direktør Jacob Madsen og hustru Olga Madsens Fond, Elna og Jørgen Fagerholt Pedersens Kræftforskningsfond, Eva og Henry Frænkels Mindefond, Manufacturer Einar Willumsen's memorial team, Fonden til Lægevidenskabens Fremme, Grosserer M. Brogaard og Hustrus Mindefond, Højmosegård-Legatet, Janssen-Cilag, S.A., Karen A. Tolstrups fond, Krista og Viggo Petersens Fond, Købmand Sven Hansen og hustru Ina Hansens Fond, Meta og Håkon Baggers Fond, Reinholdt W. Jorck og hustrus Fond
- Study start
- Mar 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Mar 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.
Observational study investigating prognostic factors in newly diagnosed and relapsed multiple myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic markers and gene expression profiling (myeloma cells from fresh bone marrow samples). Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood samples.
Detailed description
Multiple myeloma (MM) is an incurable cancer. The disease can often be brought to a halt with chemotherapy which in younger patients is accompanied by stem cell transplantation. But the disease relapses almost invariably. Cytogenetic changes in the myeloma cells can serve as prognostic markers. Accordingly, 25% of the patients show changes associated with a prognosis so poor that they should probably receive experimental treatment right from the start. Nevertheless, a part of these patients survive much longer than expected. Thus, the prognosis must depend on additional genetic events.
The aim of this project is to widen the investigators knowledge of the nature, chronology and prognostic value of the genetic events in MM in order to improve the risk stratification of the patients and hence the choice of treatment. Using cytogenetics (interphase FISH) and molecular biological analyses (SNP, GEP, miRNA) the investigators will study the changes in the myeloma cells. The investigators will search for genetic and clinical differences between patients within the same cytogenetic group and between patients at diagnosis and at relapse. The study population will consist of 100 newly diagnosed patients and 100 relapse patients included prospectively over a 2-year period in a cooperation between the four departments of hematology in Zealand, Denmark.
Hypotheses:
- Early relapse depends on a) molecular defects in the myeloma cells detectable with FISH, GEP, SNP and/or miRNA analyses, and b) the acquisition of new mutations resulting in chemotherapy resistance and increased prolific capacity.
- The progressive reduction of event free survival seen with every relapse until the disease turns refractory can be explained by selection of critical mutations.
- The cytogenetic changes associated with poor prognosis represent a heterogenous group of patients in whom the responsible genetic events remain unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed patients | – | Procedure: Bone marrow examination, Procedure: Blood samplesNewly diagnosed high-dose therapy candidates. Participation means bone marrow examination (donating 7.5 ml of fresh bone marrow) and blood samples (24 ml of peripheral blood) for biochemical and genetic analyses regarding multiple myeloma, and granting access to clinical data relating to multiple myeloma. |
| Relapse patients | – | Procedure: Bone marrow examination, Procedure: Blood samplesFormerly high-dose treated patients with progressive disease. Participation means bone marrow examination (donating 7.5 ml of fresh bone marrow) and blood samples (24 ml of peripheral blood) for biochemical and genetic analyses regarding multiple myeloma, and granting access to clinical data relating to multiple myeloma. |
| Healthy controls | – | Procedure: Bone marrow examinationHealthy blood and bone marrow donors. Participation means bone marrow examination (donating 7.5 ml of fresh bone marrow) for genetic analyses serving to compare normal bone marrow with bone marrow from multiple myeloma patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed and/or treated at departments of hematology. Healthy controls.
Key inclusion criteria (2 listed)
- patients newly diagnosed with multiple myeloma and at the same time eligible for high dose chemotherapy and autologous stem cell transplantation
- patients with multiple myeloma experiencing relapse after high dose chemotherapy and autologous stem cell transplantation
Key exclusion criteria (2 listed)
- for newly diagnosed patients: age or comorbidity preventing high dose chemotherapy and autologous stem cell transplantation,
- for all patients: age below 18, physical or psychological incapability to give an informed consent.
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 |
|---|---|---|
| Bone marrow examination7.5 ml of iliac crest bone marrow drawn in addition to diagnostic samples. | Procedure or surgery | Healthy controls, Newly diagnosed patients, Relapse patients |
| Blood samples24 ml of cubital vein blood drawn in addition to diagnostic samples. | Procedure or surgery | Newly diagnosed patients, Relapse patients |
Primary outcome
Molecular characteristics (by FISH, SNP, GEP, miRNA)
Time frame: 0-3 years
2 secondary outcomes
Event free survival (EFS)
Time frame: 0-10 years
Overall survival (OS)
Time frame: 0-10 years
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 7 Jan 2016.
- Derived from this study: PubMed 27027250Hermansen NE, Borup R, Andersen MK, Vangsted AJ, Clausen NT, Kristensen DL, Nielsen FC, Gimsing P. Gene expression risk signatures maintain prognostic power in multiple myeloma despite microarray probe set translation. Int J Lab Hematol. 2016 Jun;38(3):298-307. doi: 10.1111/ijlh.12486. Epub 2016 Mar 29.
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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.
N Emil U Hermansen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Peter Gimsing, MD, DMSc study chair
Copenhagen University Hospital, Rigshospitalet
Annette J Vangsted, MD, DMSc study chair
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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 7 Jan 2016. 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 Denmark. 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?
Molecular characteristics (by FISH, SNP, GEP, miRNA) (time frame: 0-3 years). 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 NCT00639054, 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 7 Jan 2016.