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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
  Purpose

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
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)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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 ClinicalTrials.gov identifier: NCT01619358

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

Locations
Singapore
Nationa University Hospital Recruiting
Singapore, Singapore
Contact: Wee Joo Chng, PhD    +65 6779 5555    Wee_Joo_Chng@nuhs.edu.sg   
Principal Investigator: Wee Joo Chng, PhD         
Sponsors and Collaborators
National University Hospital, Singapore
  More Information

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01619358     History of Changes
Other Study ID Numbers: 2012/00058
Study First Received: April 2, 2012
Last Updated: December 10, 2013
Health Authority: Singapore: Domain Specific Review Boards

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

ClinicalTrials.gov processed this record on November 19, 2014