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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Options for Transplant-Ineligible Myeloma Patients
The FDA has approved Sarclisa with RVd for transplant-ineligible myeloma patients as a first line or induction therapy.
The reason why some newly diagnosed MM patients are transplant in-eligible is because their oncologist considers them to be too frail to have an ASCT. Their oncologist considers the rigors of an ASCT to be too much for these patients to handle.
This approval by the FDA means that oncology is taking frail NDMM patients who can’t handle an ASCT and saying that they are able to handle the rigors of a quadruplet chemotherapy regimen.
As a long-term MM survivor, I’ve seen NDMM patients face a singlet, doublet, triplet and now quadruplet first line chemotherapy regimen as the FDA approved standard-of-care therapy.
Both PFS. OS and adverse events have steadily increased for all NDMM patient over my 30 plus years living with MM. And if any NDMM patient wants to undergo more toxicity (more chemo) for their induction therapy in an effort to possibly live longer, that’s fine.
But please understand that with increased toxicity comes probable reductions in quality of life. The more chemo the NDMM has, the worse they will feel- short or long-term.
RVd or revlimid, velcade and dexamethasone was the standard for transplant-ineligible NDMM patients and produced serious improvements when compared to the previous standard-of-care therapy.
I am simply saying that transplant-ineligible patients are too frail to withstand an ASCT and may not want to undergo the rigors of a quadruplet therapy.
Consider less toxic therapies such as revlimid and dexamethasone or RVd lite. If you would like to learn more about less toxic FDA approved therapies or non-conventional therapies for MM, email me at David.PeopleBeatingCancer@gmail.com
Thank you,
David Emerson
- MM Survivor
- MM Cancer Coacy
- Director PeopleBeatingCancer
FDA Approves Isatuximab With VRd as First-Line Option for Transplant-Ineligible Multiple Myeloma
“The FDA approved isatuximab (Sarclisa; Sanofi-Aventis) with bortezomib, lenalidomide, and dexamethasone (VRd) for adults who cannot receive autologous stem cell transplant to treat their newly diagnosed multiple myeloma (MM).1
“The PFS benefit, to be honest, is very significant, both from a clinical and a statistical point of view,” Facon said.2 “One thing is that the VRd control arm did very well—you will not see so many VRd regimens doing so well…”
The 446 patients were randomly assigned 3:2 to receive either isatuximab with VRd or just VRd. The primary end point was PFS as assessed by independent reviewers, and the quadruplet regimen delivered, with a 40% reduction in risk of disease progression or death (HR, 0.60; 95% CI, 0.44-0.81; P = .0009).
At 60 months, PFS rates were
- 83.2% in the isatuximab-VRd arm
- and 45.2% in the VRd arm.2
The median PFS was not reached in the isatuximab-VRd arm vs 54.3 months (95% CI, 45.2–not reached) in the VRd arm…1
Adverse reactions occurring in at least 20% of participants included upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, and pneumonia,1 but no new safety signals were seen.1
Grade 3 or greater treatment-emergent adverse events were seen in 91.6% of patients taking isatuximab-VRd and 84% of those taking VRd.2 The incidence of serious adverse events leading to discontinuation was similar between the arms, at 22.8% and 26%, respectively.
Treatment-emergent adverse events
“Whereas adverse events may or may not be related to a treatment, a TEAE is distinguished by its appearing specifically while treatment is ongoing or very soon thereafter, often with an infusion therapy or a treatment that requires multiple visits over time.