The International Waldenstrom’s Macroglobulinemia Foundation (IWMF) recently hosted a webinar presentation on February 9, 2021. This webinar, titled “Why Clinical Trials Matter and How to Find the Right One for You,” was presented by Neena Kennedy, BSN, RN, OCN, who serves as Clinical Trial Nurse Navigator, for the Leukemia & Lymphoma Society (LLS). The primary focus of the presentation was to inform patients about trials and how they can get involved if they feel that a trial is the best option for them.

About Waldenström’s Macroglobulinemia (WM)

Waldenström’s macroglobulinemia, which is also known as lymphoplasmacytic lymphoma, is a rare type of blood cancer that affects two types of B lymphocytes, including plasma cells and lymphoplasmacytoid cells. A distinct characteristic of this type of cancer is the presence of a high concentration of IgM antibodies. It is a slow progressing form of blood cancer, and many patients can lead active lives. While it cannot be cured, it is treatable; some patients are able to experience years of remission without symptoms. There are only about 1,500 new cases per year in the U.S. Although it mostly occurs due to sporadic genetic mutations, a family history increases risk. Symptoms include vision loss, headaches, enlargement of the lymph nodes, liver, and spleen, bleeding nose and gums, weight loss, fatigue, and general weakness. To learn more about WM, click here.

Clinical Trial Basics

Neena touched on the basics of clinical trials first. The goals of a clinical trial may include:

• Studying an experimental therapy or a potential new use for an already approved therapy
• Comparing an experimental therapy with the current standard therapy
• Increase survival or survival without active disease
• Improve quality of life

Trials are usually divided into four phases:

• Phase I is small scale and generally evaluates dosage, administration, safety, and side effects
• Phase II may be larger in scale and tests safety and overall effectiveness
• Phase III evaluates safety and effectiveness on a larger scale; may also compare with other current treatments
• Phase IV gathers further data following FDA approval

As for patients, getting involved can present several upsides and downsides such as:

PROS

• Scientific contribution to the patient community
• Early access to new treatments
• Close monitoring of participants
• Access to highly experienced physicians
• The drug being tested is free

CONS

• Treatment may not be effective
• Risk of serious side effects
• May not receive the new drug
• Often requires travel and time away from family, work, etc.

Dispelling Myths

Neena also dispelled some myths about trials; for instance, some patients have come to believe that trials are free, but only the drug being tested in free. Often the patient must incur costs for travel and other expenses. Others may think that trials are only a last resort, but it is possible to join a clinical trial before receiving any other treatment. Some patients also have a fear that they will join a trial and then not receive the drug; however, the use of placebos is becoming less common in trials involving serious, life-threatening illnesses. 

Getting Involved in Trials

Neena encourages patients interested in trials to talk to their physician about them at every opportunity. Finding a trial that’s right for you can be challenging, but Neena recommends starting at clinicaltrials.gov, where all trials are required to register. Neena also recommends patients living with WM or other blood cancers to seek assistance from the LLS Clinical Trial Support Center. The center can help patients find trials, answer questions, and serve as advocates during the clinical trial process.

For more information about the Clinical Trial Support Center, click here.

To learn more about the LLS, click here.

To learn more about the IWMF, click here.