I am feeling a bit dark in this post-election miasma – a sense of the unknown with respect to where the new government is headed; similarly, living with multiple myeloma often feels as if I am heading into the unknown. And it is a matter of trust in both cases, which spells the difference between psychological comfort and distress. Add to this a sense of powerlessness and multiple physical difficulties, and the MM patient could be pretty unhappy. YET, I see the opposite in our support group – our people are optimistic and determined. However, in the new political environment, loss of insurance coverage and/or the lifting of the pre-existing condition ban are real possibilities. Best to stay alert, be patient, and perhaps be politically active.
Continuing concerns for MM patients and their caregivers include:
- deciding which research to read and rely on;
- deciding which MM and other specialists to consult; and
- managing the financial burden of myeloma.
We can access an overwhelming amount of information from publications and websites. It is very difficult to interpret and apply to our individual condition. Thus, I consult SmartPatients daily and scan one or two reliable websites including myeloma.org. I am currently reading Gene by Siddhartha Mukherjee to help me understand the ASH presentations.
What would participation in a clinical trial mean for an MM patient. On the one hand, patients are excited and hopeful that the most recently approved medicines (four in 2015 alone) will work. On the other hand, participating in a clinical trial may mean foregoing those medicines. This is a conundrum, and here are my thoughts:
We are encouraged to consider a clinical trial at some point in our disease process; this is a very important and very personal decision. Any seminar or webinar will show slides of hundreds of patients in clinical trials. The courage of those patients leaves me awestruck. Many websites provide access and filters to the 2,000 or so MM trials being run, many of which are not worth considering because of poor design or because we don’t meet the criteria. Publish or perish still rules the world of academia. Let’s take an oppositional approach for a moment and list reasons for not participating in a clinical trial:
- AVAILABILITY OF APPROVED MEDICINES: With the availability of new medicines and evidence that they have worked in some patients, have you tried them all? If you are being encouraged to participate in a clinical trial instead, find out why.
- SAFETY: Phase I participation can be dangerous, as the researchers determine how large a dose can be given while you remain standing, even though much pre-clinical work has been done. Do not forget that clinical trials get shut down because patients experience terrible unexpected side effects.
- INCONVENIENCE: The monitoring requirements may be onerous, particularly if you live far from the enrollment site.
- SELF-INTEREST OF THE RESEARCHERS:Researchers must continue to research, which requires money, which requires publication, which requires MM patients. It is natural for a physician/researcher to want to enroll patients in the trials available in his/her practice/center. Think carefully as to what the trial will provide you; this is the time for selfishness, as well as altruism.
- FOREGONE ALTERNATIVES:Any treatment necessarily means that another treatment is foregone for the length of the chosen treatment. Given the state of knowledge, it is critical to obtain answers as to which medicines might be excluded in the future after you have participated in a clinical trial, if your disease progresses. As the disease progresses, we are told, the clones develop. The clinical trial may not be targeting the ones that matter, although the approved medicines may not either.
There is no hard and fast conclusion to these arguments.
We MM patients will be seeing numerous specialists and experience many physical problems over many years; not many diseases involve such intensity over a long period of time. Reasons for establishing a relationship with a major medical facility associated with a medical school and teaching hospital might include:
1) Availability of more specialists to address side effects, which inevitably arise. Sometimes an appointment needs to be had very quickly, which your principal MM doctor should be able to arrange.
2) Opportunity for the principal MM doctor to attend more conferences.
3) Opportunity for your principal MM doctor to be involved in research.
4) Availability of more clinical trials.
5) More current imaging devices.
A “second opinion” can be the beginning of a ”second relationship” with the consulting MM doctor. Particularly when a relapse occurs, you will want to consult with your second relationship quickly.
As our treatments are effective, we live longer and experience more side effects. It is unpredictable which patients will experience which side effects. For me, I was stunned with a complex of side effects from Kyprolis®/Pomalys®t/dex. I switched to this protocol about six months ago, as the effectiveness of Velcade®/Revlimid/dex diminished. The term “side effect” does not capture the seriousness of “dyspnea” (shortness of breath), elevated blood pressure, hand tremor and fatigue, all of which came on powerfully and have not disappeared. I have had to eliminate Kyprolis from the regimen and lower my dex dosage; fortunately, my myeloma numbers have remained steady and low.
Although unknown to me when I started on Kyprolis, about one out of three of patients in the Kyprolis clinical trial experienced shortness of breath. As there are grades/stages of dyspnea, as there are of other side effects, I would have liked a discussion about this prior to starting the Kyprolis protocol. Even with this knowledge, it would have been difficult to imagine how serious shortness of breath is or to think that a hand tremor would develop in me. So it is not just a matter of knowing what side effects occurred in the clinical trials; try to determine the percentage of patients experiencing them and the grade of the side effects. I have never heard patients get to this level of detail in my 12 years of support group participation. And I do not know whether oncologists have these discussions. A shift in work, exercise, lifestyle has to be considered whenever a new protocol is considered. It is important to ask yourself if you want to take a medicine where 1 out of 3 people will be harmed, perhaps permanently. Determine if there are alternative treatments.
Remember that “post-marketing” experience (i.e., after a medicine has been approved) may turn up additional side effects. Since the medicine, once approved, may be used in a different type of patient than those in the clinical trials, it is essential that you ask your MM specialist about the details of the trials that led to approval. You can post questions on SmartPatients, talk to other patients at IMF patient-family seminars and quiz members of your support group (if there is one in your area).
Four days to go until ASH! I will be on the lookout for presentations on managing side effects.