Clinical Trial Information
The importance of clinical trials in multiple myeloma cannot be overstated. Clinical trials are critical to answering questions about the effectiveness and safety of cancer therapies. No matter the current stage of your disease, always ask your oncologist about potential opportunities for you to participate in clinical trials.
By participating in a clinical trial, you may be treated with therapies in various stages of development. A main goal of trials is to find out more about the treatment being studied.
Find out before you enroll so you know what, if any, costs to expect from involvement in a clinical trial. Your insurance may cover routine patient care costs for those enrolled in clinical trials.
In open-label trials, you and your oncologist will know if you are taking the study drug. “Blinded” trials generally compare new therapies and/or new regimens with the best current options for standard care based on the patient’s specific condition and type of myeloma. The table below explains details.
No matter which regimen you are assigned, you will be receiving treatment associated with the clinical trial process, along with the additional tracking and checkups required. You also will have the satisfaction of contributing to the development of new options for yourself and others.
Without the hundreds of patients with multiple myeloma who have already participated in recent clinical trials, today’s new drugs and treatment regimens would likely not be available. We encourage you to ask about clinical trial options that are right for you and let your oncologist know if you are interested in participating.
Clinical Trial Phases
Studies in this phase generally are the first to test an experimental drug or new treatment regimen to determine safety, a safe dosage range, and side effects.
In Phase II trials, the drug or treatment is given to a larger group of people with the disease to see if it is effective and to continue to evaluate its safety.
Once preliminary evidence suggests effectiveness and safety, the drug or treatment regimen is given to an even larger group of people with the disease to confirm effectiveness, monitor side effects, compare it to commonly used therapies, collect additional safety information, and prepare the data for submission to the FDA for potential marketing approval.
These studies are conducted after the drug has been approved by the FDA to gather additional information about the drug's risks and benefits.
Clinical Trials Phases as Adapted from the National Institutes of Health
Clinical Trials - Enrollment issues
Approximately 20 percent of adult cancer patients are potentially eligible for clinical trials, yet only 3 to 5 percent participate. This adds considerable time to enrolling trials and significantly slows the pace of progress in improving cancer treatment. If you are interested in participating in a clinical trial, let your healthcare team know early on so that they can consider clinical trials as part of your treatment options. Of the 20,000 plus newly diagnosed myeloma patients in 2009, 10 percent – some 2,000 patients – are enrolled in clinical trials. This has contributed to ongoing clinical investigation in a rare cancer that normally might not receive much attention.
The Patient Advocate Foundation sites some reasons patients might not participate in a clinical trial:
- Not meeting the eligibility criteria
- Not aware of the availability of trials
- Don’t know how to locate a trial
- Practical or personal obstacles, such as distance, to the closest trial
- Financial inability to participate, especially for trials that require travel or relocation for a time
- Suspicions about and fear of the process or researchers
- Don’t want to go against doctors’ wishes
It’s important that you raise the subject of clinical trials, even if your healthcare team doesn’t, so that you can make sure all areas of potential treatments are explored as you are designing the best plan for you.
If you are interested in a clinical trial, you should not hesitate to ask your oncologist about whether there are trials that might be right for you.
How to Access Clinical Trials
Clinical trials take place in selected doctors' offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals in cities and towns across the United States and in other countries. They may include participants at one or two highly specialized centers, or they may involve hundreds of locations at the same time.
If you are interested in taking part in a clinical trial, talk with your oncologist to let him or her know you are interested. The people in your support group and the multiple myeloma organizations are likely to know about trials. Links to clinical trial websites are listed below, and you can register with them for ongoing updates. Information also is available from the National Cancer Institute’s Cancer Information Service (CIS). Information specialists at the CIS can provide detailed information about specific ongoing clinical trials using PDQ (Physician Data Query).
Here is a list of possible resources to explore:
- PDQ (Physician Data Query) is the National Cancer Institute's comprehensive cancer database, which contains cancer information summaries, listings of clinical trials, and directories of physicians and organizations involved in cancer care. It is used by health professionals and patients to find a broad range of information about cancer. http://www.cancer.gov/cancertopics/pdq. Call 1.800.4.CANCER for more information on clinical trials
- National Cancer Institute web site provides information about clinical trials and links to PDQ. http://www.cancer.gov/clinicaltrials/. Call 1.800.4.CANCER for more information on clinical trials
- National Institutes of Health
ClinicalTrials.gov Web site lists federally
and privately-supported clinical trials for
a wide range of diseases, including cancer
and other conditions. For information
specific to Multiple Myeloma visit
http://www.clinicaltrials.gov/ct2/results?term=multiple+myeloma - MMRF Clinical Trial Matching Service from the Multiple Myeloma Research Foundation lists clinical trials at http://www.multiplemyeloma.org. Call toll free 1.866.603.MMCT(6628)
For more information and other links to trial clearing houses, visit http://www.clinicaltrials.gov/.
*Adapted from the Patient Advocate Foundation.
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WORKING WITH YOUR TEAM
It’s a two-way street: Your oncologist and your medical team learn as much from you, your cancer and your body, as you learn from them. You need to keep them informed so they can take their best shot at helping you do your best.
