Therapeutic Advances

G. David Roodman, MD, PhD,
Professor of Medicine
University of Pittsburgh Medical Center
Pittsburgh, PA

Kenneth C. Anderson, MD,
Kraft Family Professor of Medicine
Harvard Medical School
Boston, MA

Statement of Need
In 2007, it was estimated that 19,900 new cases of multiple myeloma (MM) would be diagnosed, and 10,790 deaths would be attributed to the disease. MM is incurable; though with high-dose chemotherapy and stem cell transplant, the median overall survival rate approaches 5 years. Unfortunately, the majority of patients are not eligible to undergo stem cell transplant because of age (median age at onset is 66 years) or poor performance status and receive treatment with oral chemotherapy alone. In addition, adverse effects from the chemotherapy, such as peripheral neuropathy and deep vein thrombosis (DVT), as well as complications of the disease itself, including skeletal morbidity and renal failure, can greatly impact overall survival and/or patient quality of life, emphasizing the importance of effective supportive care strategies to improve patient quality of life and eliminate the need for dosage reductions or discontinuation of therapeutic agents.

New combination therapies incorporating novel targeted agents offer potentially more effective treatments with less toxicity, even in patients who harbor poor prognostic clinical indicators, such as loss of chromosome 13 (del13), age > 70 years, and elevated serum levels of β2-microglobulin, or who have significant comorbidities at baseline, including renal insufficiency or peripheral neuropathy. These novel agents, which were recently investigated in the relapsed/refractory setting, have now shown impressive efficacy in the frontline setting as well. The optimal dosing and scheduling of novel agents, as well as how best to incorporate them into existing treatment strategies, is currently under investigation. At the end of this activity, healthcare professionals will be able to discuss the latest data concerning safety, efficacy, and patient selection considerations in treatment regimens (including novel agent–based regimens) for patients with MM and evaluate factors impacting the choice of therapy.

Target Audience
This activity is intended for hematologists, oncologists, nurses, pharmacists, and other healthcare professionals interested in the treatment of patients with MM.

Educational Objectives
Upon completion of this activity, healthcare professionals will be able to:
1. Assess the safety and efficacy of novel agents for the treatment of newly diagnosed MM and discuss factors impacting the choice of therapy.
2. Review the safety and efficacy of novel agents for the treatment of
relapsed/refractory MM and discuss factors affecting the choice and sequence of therapy.
3. Summarize common adverse effects associated with novel therapies and discuss their impact on the management of patients with MM.
4. Discuss management strategies for patients with MM who present with lytic bone disease, and evaluate appropriate treatment options.
5. Evaluate therapeutic options and management strategies for patients with MM who present with renal impairment.

Method of Participation
This activity will utilize multiple methods of participation to engage attendees and enhance the learning process.

Accreditation

Physicians: The CBCE™ (The Center for Biomedical Continuing Education) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. This CME activity was planned and produced in accordance with the Essential Areas and policies of the ACCME.

The CBCE designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in this activity.

Physician Assistants: AAPA accepts certificates of participation for educational activities certified for Category 1 credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 1.0 hour of Category 1 credit for completing this program.

Nurses: The CBCE™ (The Center for Biomedical Continuing Education) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

The CBCE designates this educational activity for 1.0 contact hour. Accreditation by the American Nurses Credentialing Center's Commission on Accreditation refers to recognition of educational activities and does not imply approval or endorsement of any product.

Pharmacists: The CBCE™ (The Center for Biomedical Continuing Education) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.
CPE Credit: 1.00 contact hour or 0.100 CEU Universal Program Number: 195-000-08-007-H01-P

Certificate
The Evaluation and Request for Credit Form must be completed and returned to the CBCE following this activity to obtain credit. Participants will receive their certificate 4-6 weeks after submission of the form.

Acknowledgement of Commercial Support
The CBCE gratefully acknowledges the educational grant provided by Millennium Pharmaceuticals, Inc.

Educational Inquiries
For further information, please contact the CBCE, 1707 Market Place Blvd., Suite 370, Irving, Texas 75063; Telephone: (214) 260-9024; Fax: (214) 260-0509; E-mail: info@thecbce.com.

Disclaimer
The content and views presented in this educational activity are those of the faculty and do not necessarily reflect the opinions or recommendations of the CBCE or Millennium Pharmaceuticals, Inc. This material has been prepared based on a review of multiple sources of information, but is not exhaustive of the subject matter. Participants are advised to critically appraise the information presented, and are encouraged to consult the available literature on any product or device mentioned in this program.

Disclosure of Unlabeled Uses
This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the US Food and Drug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product or consult the Physicians' Desk Reference.

Disclosure of Financial Relationships With Any Commercial Interest
As a provider accredited by the ACCME, it is the policy of the CBCE to require that everyone who is in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest, and identify and resolve all conflicts of interest prior to the educational activity. The CBCE defines "relevant financial relationships" as any amount occurring within the past 12 months.

Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (eg, stocks, stock options, or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities for which remuneration is received or expected. The CBCE considers relationships of the person involved in the educational activity to include financial relationships of a spouse or partner.

Faculty who refuse to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author, and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the educational activity. For an individual with no relevant financial relationship(s), the participants must be informed that no relevant financial relationship(s) exists.

Disclosure of Potential Conflicts of Interest
The CBCE assesses conflicts of interest with its faculty, planners, and managers of CBCE activities. Identified conflicts of interest are thoroughly evaluated by the Planning Committee for fair balance, scientific objectivity relative to studies utilized in this activity, and patient-care recommendations. The CBCE is committed to providing its learners with high-quality, unbiased, and state-of-the-art education.

The following faculty have reported real or apparent conflicts of interest, and these conflicts have been resolved through a peer-review process:

G. David Roodman, MD, PhD
Consultant
Amgen Inc.
Millennium Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corporation
Salary
University of Pittsburgh

Kenneth C. Anderson, MD
Consultant
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corporation
Honoraria
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corporation

The CBCE receives educational grants from the pharmaceutical industry and other commercial sources. Companies providing grants to the CBCE include the commercial supporter of this activity as well as the manufacturer(s) of certain drugs and/or devices discussed in this activity.

Staff Disclosure
The CBCE staff have declared they have no financial relationships that require disclosure.