Multiple Myeloma

Clinical Trials

Clinical trials present many potential benefits, such as the opportunity for patients to access cutting-edge treatments that are not yet widely available. In fact, many of the advances in cancer treatment are helping to save lives today because of the research conducted through trials. Depending on your diagnosis and other factors, a clinical trial may be an option, so it’s important to understand what it is and what it may mean for you.

Clinical trials are research studies that do the following:

  • Evaluate the safety and effectiveness of a medical strategy, treatment or device.
  • Develop “standards of care” by helping identify which treatments work best for certain illnesses or groups of people.
  • Offer opportunities for people with cancer to help others by being involved in clinical research.

Sponsors of clinical trials include government agencies (such as the National Cancer Institute), independent groups of doctors and health care institutions, or the pharmaceutical or biotechnology industries. However, no treatment or device is released for public use in the United States until it is approved by the U.S. Food and Drug Administration (FDA).

Types of Clinical Trials

There are three types of clinical trials.

  • Treatment Trials evaluate whether a new type of treatment (drug, surgery, radiation therapy) or a combination of treatments is better than the treatment options that are currently available.
  • Quality-of-Life Trials study ways to improve the quality of life for people being treated for cancer and cancer survivors who experience cancer-related and treatment-related symptoms. This type of trial may evaluate the effects of such things as nutrition, group therapy or counseling.
  • Prevention, Screening and Diagnostic Trials assess ways to reduce the chance of getting cancer in general. In these trials, which may be treatment or nontreatment trials, many participants do not have cancer, but some have had cancer and are at risk of the cancer returning (recurring) or a second cancer type developing. Sometimes these trials consist of simply completing questionnaires and providing medical information.

What to Expect

When you volunteer to participate in a clinical trial, you will receive specific instructions and an Informed Consent form. You are encouraged to ask questions about anything you don’t understand before signing and returning the form. This is the ideal time to talk with your medical team about the many falsehoods that persist about clinical trials. For example, although there is fear to the contrary, participants are guaranteed to receive, at minimum, the current standard of care during the trial.

Trials are carefully thought out, planned and performed in an extremely consistent manner so that all patients are treated exactly the same, from medication dosage and schedule to the frequency of follow-up appointments. Institutional review boards or ethics committees carefully set up safeguards to make sure that all patients in the clinical trial remain safe throughout the process. Whether you’re at a small hospital or a large facility, your medical team is responsible for diligently following all of the same protocols and safety measures for your treatment plan across the board. You will be carefully monitored throughout the clinical trial. Even after the treatment ends, you will continue to be in close contact with the medical team.

Clinical trials present some potential risks, such as side effects. Almost every type of cancer treatment has side effects, and the treatments used in clinical trials are no different. If you consider volunteering for a clinical trial, talk with your medical team about what you can expect so you are not surprised by any effects.

Participation is always voluntary, even after the study begins. Even though you sign an agreement saying that you understand the potential risks involved, you can decide to leave the trial at any time. If your expectations aren’t met or if you experience too many side effects, you can withdraw and return to standard of care treatment.

Cost is a common consideration with clinical trials. Routine patient care costs typically include those related to doctor visits and hospital stays. Some testing procedures that are part of standard care may be covered by your insurance. Research costs, which are directly related to the clinical trial and include drugs and procedures, are typically covered by the trial sponsor. Before dismissing the idea of participating because of the cost, research available resources and explore your insurance plan benefits. You may find that you can have access to an innovative treatment and be an integral part of cancer research without incurring a great deal of additional expense.

 

Relapsed or Refractory Multiple Myeloma

Multiple myeloma commonly comes back (relapses) after treatment. A relapse can happen weeks, months or even years after initial treatment has ended. Treatments often reduce the amount of myeloma cells, but some can remain undetected and continue to grow. Keeping follow-up appointments is important because finding any recurrence early is key to successful treatment. Your doctor will ask questions about any ongoing symptoms you may be having, especially those related to recurrence and long-term side effects of treatment.

Sometimes during treatment, multiple myeloma stops responding to the treatment. When this occurs, it is called refractory myeloma. Patients may not respond to initial therapy or may stop responding after being on a treatment for a length of time. If this happens, your doctor may request additional tests that could be used to restage your multiple myeloma. If a new stage is assigned, it will likely change your treatment options. This is also a good time to consider getting a second opinion.

Many doctors now treat multiple myeloma similarly to a chronic condition. Recent breakthroughs in research have resulted in improved treatment regimens for people with relapsed or recurrent multiple myeloma. New regimens include inhibiting the growth of cancer cells with next-generation proteasome inhibitors, using the immune system to help fight cancer with immunotherapy and altering the immune system with immunomodulatory drugs (see Treatment Options). Multiple drugs are also being researched in late-stage clinical trials for relapsed or recurrent multiple myeloma. Ask your doctor if a clinical trial may be an option for you.

 

 

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