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Status unknownNCT01619358Updated Dec 11, 2013

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

An observational study in Multiple Myeloma, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by National University Hospital, Singapore · Observational

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
21 Years and older
Sex
All
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Study 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
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Conditions studied

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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 150 is close to the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • All Patients fulfilling IMWG diagnostic criteria for myeloma

Exclusion criteria

Exclusion Criteria:

  • Unable to take consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
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What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

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Study locations

1 of 1 sites recruiting
  • Nationa University Hospital
    Singapore, Singapore
    Recruiting
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References and documents

Publications

  • Bergsagel PL, Kuehl WM, Zhan F, Sawyer J, Barlogie B, Shaughnessy J Jr. Cyclin D dysregulation: an early and unifying pathogenic event in multiple myeloma. Blood. 2005 Jul 1;106(1):296-303. doi: 10.1182/blood-2005-01-0034. Epub 2005 Mar 8. PubMed 15755896 ↗
  • Chng WJ, Braggio E, Mulligan G, Bryant B, Remstein E, Valdez R, Dogan A, Fonseca R. The centrosome index is a powerful prognostic marker in myeloma and identifies a cohort of patients that might benefit from aurora kinase inhibition. Blood. 2008 Feb 1;111(3):1603-9. doi: 10.1182/blood-2007-06-097774. Epub 2007 Nov 15. PubMed 18006703 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01619358
Lead sponsor
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Jun 14, 2012
Start date
Mar 2012
Primary completion
Feb 2017 (estimated)
Last update
Dec 11, 2013

Study contacts

Wee Joo Chng, PhD
Contact
Wee_Joo_Chng@nuhs.edu.sg
+65 6779 5555

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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