The Molecular Characterization of Multiple Myeloma at Relapse

Multiple Myeloma Clinical Trial

— MM-FISH/DNA  

Official title:

The Molecular Characterization of Multiple Myeloma at Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639054
• Other study ID #: 959593931/Emil Hermansen
• Secondary ID: H-B-2007-117
• Status: Completed
• Phase: N/A
• First received: March 11, 2008
• Last updated: January 6, 2016
• Start date: March 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical 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). Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood samples.

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:

1. 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.

2. The progressive reduction of event free survival seen with every relapse until the disease turns refractory can be explained by selection of critical mutations.

3. The cytogenetic changes associated with poor prognosis represent a heterogenous group of patients in whom the responsible genetic events remain unknown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• Bone marrow examination
7.5 ml of iliac crest bone marrow drawn in addition to diagnostic samples.
• Blood samples
24 ml of cubital vein blood drawn in addition to diagnostic samples.

Locations

Country	Name	City	State
Denmark	Multiple Myeloma Research Laboratory, Dept Hematology, Cph Univ Hosp Rigshospitalet	Copenhagen	Capital Region

Sponsors (21)

Lead Sponsor

Collaborator

Rigshospitalet, Denmark

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, Fabrikant Einar Willumsens Mindelegat, Fonden til Lægevidenskabens Fremme, Grosserer M. Brogaard og Hustrus Mindefond, Herlev Hospital, Højmosegård-Legatet, Janssen-Cilag, S.A., Karen A. Tolstrups fond, Købmand Sven Hansen og hustru Ina Hansens Fond, Krista og Viggo Petersens Fond, Meta og Håkon Baggers Fond, Naestved Hospital, Reinholdt W. Jorck og hustrus Fond, Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular characteristics (by FISH, SNP, GEP, miRNA)		0-3 years	No
Secondary	Event free survival (EFS)		0-10 years	No
Secondary	Overall survival (OS)		0-10 years	No