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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
National University Hospital, Singapore Identifier:
First received: April 2, 2012
Last updated: December 10, 2013
Last verified: December 2013

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

Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: National University Hospital, Singapore Identifier: NCT01619358     History of Changes
Other Study ID Numbers: 2012/00058
Study First Received: April 2, 2012
Last Updated: December 10, 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 processed this record on September 21, 2017