Genomic-Based Diagnosis, Classification and Targeted Treatment of Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National University Hospital, Singapore
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01619358
First received: April 2, 2012
Last updated: December 10, 2013
Last verified: December 2013

April 2, 2012
December 10, 2013
March 2012
February 2017   (final data collection date for primary outcome measure)
Prospectively validate the use of gene expression profiling (GEP) for the risk-stratification and classification of MM
All patients will have additional bone marrow taken for GEP studies after informed consent at entry into the treatment protocol. CD138 positive cells will be selected using magnetic beads and RNA extracted. The quality of RNA will be checked using the Agilent Bioanalyzer. GEP will be performed using Affymetrix U133plus2.0 chip.
Same as current
Complete list of historical versions of study NCT01619358 on ClinicalTrials.gov Archive Site
  • Prospectively validate predictive biomarkers in MM
    We will prospectively validate 4 predictive makers we have previously identified for Velcade. Using diagnostic samples from patients entered into the above treatment protocol, we will assay for MYC activationusing IHC, TRAF3 inactivation using FISH for TRAF3 deletion and sequencing to check for TRAF3 mutations, NKFB index by GEP, and MYC activation index (MAI) by GEP.
  • Study the impact of different treatment phases on minimal residual disease (MRD) and their impaction outcome.

    We will be assessing MRD using 4 methods:

    1. ASO-PCR
    2. FCM
    3. sFLC
    4. Serum Heavylite
Same as current
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Genomic-Based Diagnosis, Classification and Targeted Treatment of Multiple Myeloma
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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
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients being treated with Multiple Myeloma at National University Hospital (Singapore)

Multiple Myeloma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
February 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All Patients fulfilling IMWG diagnostic criteria for myeloma

Exclusion Criteria:

  • Unable to take consent
Both
21 Years and older
No
Contact: Wee Joo Chng, PhD +65 6779 5555 Wee_Joo_Chng@nuhs.edu.sg
Singapore
 
NCT01619358
2012/00058
Yes
National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Not Provided
National University Hospital, Singapore
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP