To provide the specialized expertise needed to maximize the success of the Projects, they will be supported by five Core Facilities:
- Core A – Administrative Core Facility
- Core B – Myeloma Tissue Core Facility
- Core C – Animal Models Core Facility
- Core D – Clinical Trials Core Facility
- Core E – Biostatistics and Bioinformatics Core Facility
Core A – Administrative Core
Director: Robert Z. Orlowski, M.D., Ph.D. (MD Anderson)
Co-Director: Larry W. Kwak, M.D., Ph.D. (MD Anderson)
The Administrative Core will play the central role in this SPORE, helping both established and developmental projects focus on their translational goals, and identifying and implementing steps required to translate the research to and from the clinic to produce objective evidence of improving outcomes in multiple myeloma.
This Core’s overall goals will be to provide coordination and oversight of SPORE activities, to facilitate internal and external collaborations, as well as intramural and extramural communications, and to thereby expedite in every way possible the translational mission of the SPORE. Specific Aims of this Core are:
- Specific Aim 1: Assure the overall scientific quality and function of the SPORE, including the four Projects, five Cores, and the Developmental Research and Career Development Programs.
- Specific Aim 2: Establish and monitor compliance of SPORE activities with all general governmental and NCI-specific regulations and requirements.
- Specific Aim 3: Oversee SPORE expenditures, maintain budget information, and provide reports thereof to SPORE personnel and other responsible authorities.
- Specific Aim 4: Organize and convene all necessary meetings.
- Specific Aim 5: Administer the SPORE Developmental Research Program, as well as the Career Development Program.
- Specific Aim 6: Support the preparation and submission of all SPORE publications and other external communications.
- Specific Aim 7: Coordinate, obtain, and maintain Institutional commitments to the SPORE in Multiple Myeloma.
- Specific Aim 8: Encourage and facilitate SPORE communications, collaborations, and data and resource sharing.
- Specific Aim 9: Promote communications and collaborations with other SPORE partners in both academia and industry.
Core B – Myeloma Tissue Core
Director: Steven Kornblau, M.D. (MD Anderson)
Co-Directors: Michael Wang, M.D. (MD Anderson), R. Eric Davis, M.D. (MD Anderson), Pei Lin, M.D. (MD Anderson)
The Myeloma Tissue Core will provide basic, translational, and clinical scientists focusing on multiple myeloma with access to molecularly characterized cell line model systems, and especially to clinically annotated, fresh and frozen primary tissue samples in order to test and validate their hypotheses.
The main objective of the Myeloma Tissue Core is to work with each SPORE Project, Core, and Program to insure efficient procurement, storage, and distribution of laboratory and clinical tissue samples at the MD Anderson Cancer Center. Validated standardized operating procedures have been established for all activities, and continuous communication between the investigators, research nurses, biostatisticians, and hematopathologists will provide for optimal tissue collection, standardized processing, accurate analysis, and safe storage of each sample. These samples will be associated with relevant patient clinical and laboratory data obtained and maintained in accordance with all applicable regulatory guidelines. This Tissue Core will also be used for novel and robust biomarker development and accurate testing of translational hypotheses. There are four Specific Aims for this Core:
- Specific Aim 1: Develop and maintain a repository of intact cells, serum, DNA, RNA, and proteins derived from blood, bone marrow, and other tissue specimens obtained from patients with plasma cell dyscrasias at the MD Anderson Cancer Center.
- Specific Aim 2: Maintain a comprehensive, prospective, interactive database with detailed clinical and pathologic data for patients with plasma cell dyscrasias.
- Specific Aim 3: Facilitate inter- and intra-SPORE collaborations, and collaborations with non-SPORE investigators, through acquisition and distribution of clinical sample resources to and from SPORE investigators and others within the MD Anderson Cancer Center, as well as with other national or international sources.
- Specific Aim 4: Provide stock and customized reverse phase protein arrays to SPORE investigators.
Core C – Animal Models Core
Director: Qing Yi, M.D., Ph.D. (MD Anderson)
Co-Director: Jing Yang, Ph.D. (MD Anderson)
The dedicated personnel and facilities of the Animal Models Core (Core C) provide the program with clinically relevant animal models and expertise in animal studies essential to achieving the aims of the Projects, especially for examining the in vivo efficacy of novel agents. Core personnel work closely with SPORE investigators to plan animal studies and to develop optimal and clinically relevant mouse models of myeloma. The Department of Lymphoma/Myeloma and MD Anderson Cancer Center provide excellent access to primary myeloma samples, a myeloma tissue bank, interaction between clinical and translational research programs, and animal facilities for providing unique, clinically relevant samples to establish myeloma SCID and SCID-hu mouse models, which in turn allow the reproducibly engraftment of established human myeloma cell lines or primary myeloma cells freshly isolated from patients with MM, respectively. Establishment of myeloma in SCID-hu mice induces typical human MM manifestations including disease heterogeneity commonly seen in the clinic. The location of the Animal Models Core personnel, animal facilities, and tissue banks at the South Campus Research Buildings provides a level of integration for the Core that will maximize uniformity and use of available animal models and patients’ materials by SPORE investigators. To provide these crucial services to the SPORE projects, our Core will be guided by the following Specific Aims:
- Specific Aim 1: Provide and conduct in vivo animal modeling proposed by each project of the SPORE program.
- Specific Aim 2: Validate molecular targets and novel therapies relevant to the projects of the program.
Core D – Clinical Trials Core
Director: Donna M. Weber, M.D. (MD Anderson)
Co-Directors: Edward A. Stadtmauer, M.D. (Penn), Jorge Romaguera, M.D. (MD Anderson)
The Clinical Trials Core Facility of The University of Texas MD Anderson Cancer Center SPORE in Multiple Myeloma will translate highly promising findings with potential application to the prevention, early detection, diagnosis, prognosis, and/or treatment of multiple myeloma from the laboratory to the clinic. Clinical trials coordinated by this Core will also promote the flow of information from the clinic back to the laboratory, with the goal of helping to inform and optimize the design of future clinical interventions. In order to accomplish these objectives, the Core will have the following Specific Aims:
- Specific Aim 1: Coordinate the development, submission, and regulatory approval of the SPORE clinical trials.
- Specific Aim 2: Assist SPORE Investigators in rapidly and efficiently accruing patients to translational clinical trials emerging from SPORE projects.
- Specific Aim 3: Report adverse events to the Institutional Review Board (IRB) and appropriate agencies, and assure compliance with all applicable regulatory guidelines.
- Specific Aim 4: Provide quality control of the SPORE clinical trial data.
- Specific Aim 5: Analyze clinical trials data from SPORE studies in collaboration with the Biostatistics and Bioinformatics Core (Core E).
- Specific Aim 6: Facilitate and coordinate correlative specimen collection from patients enrolled on SPORE trials along with the Myeloma Tissue Core (Core B).
Core E – Biostatistics and Bioinformatics Core
Director: Donald Berry, Ph.D. (MD Anderson)
Co-Directors: Veera Baladandayuthapani, Ph.D. (MD Anderson), Jonas Almeida, Ph.D. (MD Anderson)
Core Investigator: Viswanathan Ramakrishnan (VCU)
The Biostatistics and Bioinformatics Core for the MD Anderson SPORE in Multiple Myeloma will serve multiple needs with respect to the planning and conduct of the SPORE research. This resource will be used for hypothesis refinement, experimental design, data management, quality control, and informative presentation of results, and will be available for all projects of the SPORE. From a biostatistical perspective, design and analysis of laboratory and clinical projects will be performed in collaboration with Berry, Baladandayuthapani, and Heather Y. Lin, Ph.D. Data from the SPORE clinical trials, laboratory projects and high-throughput genomics studies will be entered into a customized integrative database infrastructure developed by Almeida. The Biostatistics and Bioinformatics Core will augment existing MD Anderson biostatistics resources and to align these considerable resources with SPORE research objectives.
The Specific Aims of the Biostatistics and Bioinformatics Core:
- Specific Aim 1: Provide the statistical design, sample size, and power calculations for each Project.
- Specific Aim 2: Facilitate prospective collection, entry, quality control, and integration of data for the basic science experiments and clinical trials arising from the ongoing research of the SPORE.
- Specific Aim 3: Provide innovative statistical modeling, simulation techniques, and data analyses needed by the Projects and other cores to achieve their specific aims.
- Specific Aim 4: Ensure that the results of all Projects are based on well-designed experiments and are appropriately interpreted.