The Molecular Characterization of Multiple Myeloma at Relapse
MM-FISH/DNA
2 other identifiers
observational
134
1 country
1
Brief 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). Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 7, 2016
January 1, 2016
6.8 years
March 11, 2008
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Molecular characteristics (by FISH, SNP, GEP, miRNA)
0-3 years
Secondary Outcomes (2)
Event free survival (EFS)
0-10 years
Overall survival (OS)
0-10 years
Study Arms (3)
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.
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.
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.
Interventions
7.5 ml of iliac crest bone marrow drawn in addition to diagnostic samples.
24 ml of cubital vein blood drawn in addition to diagnostic samples.
Eligibility Criteria
Patients diagnosed and/or treated at departments of hematology. Healthy controls.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Herlev Hospitalcollaborator
- Zealand University Hospitalcollaborator
- Naestved Hospitalcollaborator
- Agnes og Poul Friis Fondcollaborator
- Carl og Ellen Hertzs Legat til Dansk Læge- og Naturvidenskabcollaborator
- Dagmar Marshalls Fondcollaborator
- Danish Cancer Research Foundationcollaborator
- Direktør Jacob Madsen og hustru Olga Madsens Fondcollaborator
- Elna og Jørgen Fagerholt Pedersens Kræftforskningsfondcollaborator
- Eva og Henry Frænkels Mindefondcollaborator
- Manufacturer Einar Willumsen's memorial teamcollaborator
- Fonden til Lægevidenskabens Fremmecollaborator
- Grosserer M. Brogaard og Hustrus Mindefondcollaborator
- Højmosegård-Legatetcollaborator
- Janssen-Cilag, S.A.collaborator
- Karen A. Tolstrups fondcollaborator
- Krista og Viggo Petersens Fondcollaborator
- Købmand Sven Hansen og hustru Ina Hansens Fondcollaborator
- Meta og Håkon Baggers Fondcollaborator
- Reinholdt W. Jorck og hustrus Fondcollaborator
Study Sites (1)
Multiple Myeloma Research Laboratory, Dept Hematology, Cph Univ Hosp Rigshospitalet
Copenhagen, Capital Region, DK-2100, Denmark
Related Publications (1)
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.
PMID: 27027250DERIVED
Biospecimen
Peripheral whole blood Bone marrow
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
N Emil U Hermansen, MD
Rigshospitalet, Denmark
- STUDY CHAIR
Peter Gimsing, MD, DMSc
Rigshospitalet, Denmark
- STUDY CHAIR
Annette J Vangsted, MD, DMSc
Zealand University Hospital
- STUDY CHAIR
Mette K Andersen, MD, DMSc
Rigshospitalet, Denmark
- STUDY CHAIR
Finn C Nielsen, MD, DMSc
Rigshospitalet, Denmark
- STUDY CHAIR
Dan Kristensen, MD
Naestved Hospital, Denmark
- STUDY CHAIR
Nielsaage T Clausen, MD
Herlev Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D student
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 19, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 7, 2016
Record last verified: 2016-01