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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If Even One Multiple Myeloma Patient Died As a Result of a Clinical Trial Experimental Chemo Cocktail then it is More Than a “Setback.”
Let me begin by saying that I believe multiple myeloma clinical trials can be essential to moving therapy forward for MM patients and survivors. Further, I believe that immunotherapy holds a great deal of promise for cancer patients and finally, I entered a clinical trial during my own autologous stem cell transplant in December of 1995.
Understand that my motives in participating in the trial were less than altruistic. I decided to join the clinical trial only because I had an incurable cancer with an average life expectance of 3-5 years and that a medical professional asked for my help. I thought I had only a few years left so why not?
At least I think that the guy who asked me to join the trial was a medical doctor…
My point is that approval of cancer therapies as they are now- the FDA clinical trial system to approve new therapies- is a mess. That is to say that people have a fundamental problem with clinical trials.
I believe that cancer patients are reluctant to enter clinical trials for the three reasons below.
Cancer patients feel like guinea pigs
Cancer patients feel that they might not get the most effective therapy possible and
The clinical trial therapy might be harmful (kill you).
The fact is newly diagnosed multiple myeloma patients face the almost impossible task of learning about their incurable cancer (therapies, medical insurance, side effects, language and more) in the days and weeks following their diagnosis. Believe me when I say that this is an impossible task.
If it turns out that Keytruda combined with approved myeloma therapies caused the death of one or more myeloma patients then cancer patients will have more reason than ever to not participate in a trial. Ever.
“The Food and Drug Administration (FDA) has issued an order to delay the open-label, first-in-human phase 1 MELANI-01 trial, which is evaluating the CAR T-cell product UCARTCS1A in patients with relapsed or refractory multiple myeloma, according to a press release from the product’s manufacturer.
The agency issued the clinical hold, which orders a pharmaceutical company to either delay or suspend a clinical trial, after it received a safety report that focused on a patient enrolled in the trial. The patient, who had received previous treatment with multiple lines of therapy, including autologous CAR T-cells, died after experiencing a treatment-emergent cardiac arrest…”
“The streak of positive Keytruda updates had to end somewhere. After an onslaught of upbeat trial results and regulatory news, maker Merck Monday night announced that it was pausing enrollment on a pair of phase 3 multiple myeloma studies of the med to investigate trial deaths…
The move, which comes at the recommendation of an independent data monitoring committee, comes after “more reports of death” in the Keytruda groups of studies Keynote-183, which is examining a combo of Keytruda with Celgene’s Pomalyst and dexamethasone in previously treated patients, and Keynote-185, which is marrying Keytruda with Celgene’s Revlimid in certain not-yet-treated patients…
Right now, not much else is clear; Merck couldn’t shed light on how many patients have died... And while the dearth of info makes it “difficult to draw meaningful conclusions”…
The BELLINI study was conducted in patients with relapsed or refractory multiple myeloma who had already received one to three lines of therapy. They were randomly assigned to receive either venetoclax or placebo together with bortezomib and dexamethasone.
The median PFS was doubled for patients in the venetoclax arm of the study (22.4 months vs 11.5 months; hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.44 – 0.90). Overall response rates were also significantly improved (82% vs 68% for the control).
However, the safety of venetoclax was called into question in the preplanned analysis. Patients in the venetoclax arm had a twofold increased risk for death from treatment-emergent adverse events.”
[…] Has a Multiple Myeloma Patient Ever Died In Clinical Trial? […]Reply