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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01619358
Recruitment Status : Unknown
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : June 14, 2012
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief 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

Condition or disease
Multiple Myeloma

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2012
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • Unable to take consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01619358

Contact: Wee Joo Chng, PhD +65 6779 5555

Nationa University Hospital Recruiting
Singapore, Singapore
Contact: Wee Joo Chng, PhD    +65 6779 5555   
Principal Investigator: Wee Joo Chng, PhD         
Sponsors and Collaborators
National University Hospital, Singapore

Responsible Party: National University Hospital, Singapore Identifier: NCT01619358     History of Changes
Other Study ID Numbers: 2012/00058
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases