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Trial Title:
Genomic-Based Diagnosis, Classification and Targeted Treatment of Multiple Myeloma
NCT ID:
NCT01619358
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Summary:
Multiple myeloma is an incurable bone marrow cancer characterized by an abnormal
expansion of plasma cells that secretes monoclonal immunoglobulin. Over the years, the
molecular and genetic heterogeneity of the disease have been dissected. With the
maturation of technologies, the time is ripe now to apply genomics to diagnose, classify,
risk-stratify and prognosticate myeloma in the clinical setting and use this information
to guide current treatment. The investigators hypothesize that the use of gene expression
profiling as a single test will be more economical, efficient and accurate compared to
the current standard panel of tests done at diagnosis. The investigators also hypothesize
that the investigator can use predictive markers to identify prospectively patients who
will respond to Velcade and that with more effective trebasedonatment, ability to measure
depth of response beyond conventional complete response become important since more
patients are achieving conventionally determined complete response. Using a cohort of
patients treated on a standard treatment protocol based on Velcade-based induction
treatment followed by consolidation and maintenance treatment, the investigators will
study specifically the feasibility and accuracy of gene expression diagnostics, the
predictive power of the investigators predefined predictive markers and the clinical
utility of minimal residual disease measurement in myeloma. The results of the
investigators study will allow us to improve the diagnosis, and prognostication of MM
patients
1. The investigators hypothesized that this will speed up diagnosis, provide
comprehensive information for the classification and risk stratification of MM
patients and can completely replace the current FISH assay and may be cheaper.
2. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation
will identify patients that will have a significantly better response to Velcade.
3. Modern treatment induced deeper response. More sensitive method of disease detection
will allow us to know the fully extent of response to these treatment
Criteria for eligibility:
Study pop:
Patients being treated with Multiple Myeloma at National University Hospital (Singapore)
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- All Patients fulfilling IMWG diagnostic criteria for myeloma
Exclusion Criteria:
- Unable to take consent
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nationa University Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Wee Joo Chng, PhD
Phone:
+65 6779 5555
Email:
Wee_Joo_Chng@nuhs.edu.sg
Investigator:
Last name:
Wee Joo Chng, PhD
Email:
Principal Investigator
Start date:
March 2012
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01619358
