Recently Diagnosed or Relapsed? Stop Looking For a Miracle Cure, and Use Evidence-Based Therapies To Enhance Your Treatment and Prolong Your Remission
Multiple Myeloma an incurable disease, but I have spent the last 25 years in remission using a blend of conventional oncology and evidence-based nutrition, supplementation, and lifestyle therapies from peer-reviewed studies that your oncologist probably hasn't told you about.
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Myeloma Clinical Trials Misleading
Myeloma clinical trials being misleading compared to real life outcomes should not come as a surprise to anyone. Numerous studies conclude that “stringent inclusion criteria” gives a false picture of the average myeloma patient.
The average age of newly diagnosed myeloma patients is 70. If you are in your late sixties or early seventies then you count on clinical trial results that apply to you. Unfortunately you would be out-of-luck,
The best example, in my experience, of misleading myeloma clinical trials would be NDMM considering autologous stem cell transplantation (ASCT). All clinical trials for ASCT have inclusion criteria which very well make the results of the trial not apply to you. Sadly, you will never know.
I am a long-term myeloma survivor. Years of research and personal experience have taught me about the good, the bad and the ugly of conventional myeloma. Yes, conventional myeloma therapies such as chemo, radiation and surgery are central to your myeloma experience. As is your myeloma specialist.
However, I encourage a healthy skepticism when it comes to conventional oncology. Which makes it difficult for you- I understand. But evidence-based non-conventional therapies should be an important part of your life as a MM survivor.
What are examples of strict exclusion criteria for clinical trials?
- Medical Conditions: Participants with certain medical conditions that could interfere with the study objectives or pose a risk to their health may be excluded. For example, individuals with severe heart disease, liver or kidney dysfunction, or uncontrolled diabetes may be excluded from certain trials.
- Concurrent Medications: Some trials exclude individuals who are taking certain medications that could interact with the study intervention or confound the results. This could include medications with known interactions or those that may affect the condition being studied.
- Previous Treatments: Participants who have previously received specific treatments relevant to the study may be excluded. This is to avoid confounding effects from prior therapies and to ensure a more homogenous study population.
- Age and Gender: Certain trials may have age or gender restrictions based on the condition being studied or the mechanism of action of the intervention. For example, a trial testing a treatment for menopause symptoms may exclude males, or a trial for a pediatric condition may have age restrictions.
- Pregnancy or Breastfeeding: Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period may be excluded due to potential risks to the fetus or infant.
- Psychological or Cognitive Conditions: Individuals with certain psychological or cognitive conditions may be excluded if their condition could interfere with their ability to understand the trial requirements or provide informed consent.
- Substance Abuse: Participants with a history of substance abuse or current substance abuse may be excluded due to concerns about compliance with the study protocol or potential interactions with the intervention.
- Allergies or Sensitivities: Individuals with known allergies or sensitivities to components of the study intervention may be excluded to prevent adverse reactions.
- Certain Laboratory Values: Trials may exclude participants with abnormal laboratory values outside a specified range, particularly if those abnormalities could affect the safety or efficacy of the intervention.
- Geographic Location: Some trials may have geographic restrictions due to logistical reasons or to ensure that participants can easily adhere to the study protocol and attend study visits.
Have you been diagnosed with multiple myeloma? How old are you? What symptoms have you been experiencing? Have you been given a stage yet?
Adverse events or what are commonly called side effects must be taken into account as you undergo both chemo and radiation. In my experience, conventional oncology spends little if any time educating the NDMM patient about how to handle short, long-term and late stage side effects.
man hand holding his nutritional supplemets, healthy lifestyle background.
If you’d like to learn more about both FDA approved conventional myeloma therapies as well as evidence-based non-conventional therapies such as nutrition, supplementation and exercise, send me an email David.PeopleBeatingCancer@gmail.com
Good luck,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
In Real World, Patients With Myeloma Have Worse Outcomes
“In the real world, outcomes for patients with multiple myeloma who received standard regimens were dramatically worse than those reported in clinical trials, a new study found…
The analysis, which included nearly 4000 patients with multiple myeloma, revealed that patients in a real-world setting demonstrated worse progression-free and overall survival on six of seven standard treatments compared with patients evaluated in randomized controlled trials…
Outcomes from randomized controlled trials form the basis of drug approvals but many patients in the real world do not meet the “stringent” trial inclusion criteria…
Visram and colleagues launched the current study to better understand the potential differences between real-world and clinical trial outcomes. In the analysis, the researchers compared real-world outcomes among patients receiving seven standard multiple myeloma regimens covered by Ontario’s public health plan with patient outcomes reported in phase 3 randomized controlled trials…
Regimens for newly diagnosed transplant ineligible patients included lenalidomide plus dexamethasone and triple therapy with bortezomib, lenalidomide, and dexamethasone (VRd- the FDA standard-of-care for all newly diagnosed MM patients). Regimens for patients with relapsed disease included pomalidomide plus dexamethasone or carfilzomib plus dexamethasone as well as triple combinations including carfilzomib, lenalidomide, and dexamethasone…
For these regimens, progression-free survival was at least 3-18 months longer in the clinical trial cohort, while median overall survival was at least 19 months longer compared with real-world patients, Visram explained…
The study also found that adverse effects were similar between the clinical and real-world groups…
Patients in these types of clinical trials “are just these pristine specimens of human beings except for the cancer that’s being treated,” Sekeres, of the Sylvester Comprehensive Cancer Center at the University of Miami, Miami, Florida, said in an earlier ASH press briefing…
Dunbar said hematologists and patients should consider randomized controlled trials to be “the best possible outcome, and perhaps adjust their thinking if an individual patient is older, sicker, or less able to follow a regimen exactly.””