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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00639054 |
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 our 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) we will study the changes in the myeloma cells. We 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:
Condition |
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Multiple Myeloma |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Molecular Characterization of Multiple Myeloma at Relapse |
Peripheral whole blood Bone marrow
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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N
Newly diagnosed multiple myeloma patients suitable for high-dose chemotherapy and stem cell transplantation
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R
Multiple myeloma patients experiencing relapse after high-dose chemotherapy and stem cell transplantation
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients diagnosed and/or treated at departments of hematology.
Inclusion Criteria:
Exclusion Criteria:
Contact: N. Emil U. Hermansen, MD | +45 35450798 | emil.hermansen@rh.regionh.dk |
Contact: Peter Gimsing, MD, PhD | +45 35454388 | peter.gimsing@rh.regionh.dk |
Denmark, Capital Region | |
The Multiple Myeloma Laboratory, Dept. Hematology, Rigshospitalet | Recruiting |
Copenhagen, Capital Region, Denmark, DK-2100 | |
Contact: N. Emil U. Hermansen, MD +45 35450798 emil.hermansen@rh.regionh.dk | |
Principal Investigator: N. Emil U. Hermansen, MD |
Principal Investigator: | N. Emil U. Hermansen, MD | Rigshospitalet, Denmark |
Study Chair: | Peter Gimsing, MD, DMSc | Rigshospitalet, Denmark |
Study Chair: | Annette Vangsted, MD | Herlev Hospital, Denmark |
Study Chair: | Mette K Andersen, MD, DMSc | Rigshospitalet, Denmark |
Study Chair: | Finn C Nielsen, MD, DMSc | Rigshospitalet, Denmark |
Study Chair: | Michael Pedersen, MD, DMSc | Roskilde Hospital, Denmark |
Study Chair: | Dan Kristensen, MD | Naestved Hospital, Denmark |
Responsible Party: | Rigshospitalet, Denmark ( N. Emil U. Hermansen, MD ) |
Study ID Numbers: | 959593931/Emil Hermansen, H-B-2007-117 |
Study First Received: | March 11, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00639054 |
Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: National Board of Health; Denmark: The Danish National Committee on Biomedical Research Ethics |
classification diagnosis genetics mortality pathology |
Immunoproliferative Disorders Hemorrhagic Disorders Multiple myeloma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |