James Berenson, did you turn the world of conventional myeloma therapy upside down on purpose? Your study documenting the treatment history of myeloma patients at your clinic from August 2006 to February of 2022 questions key practices of conventional standard-of-care myeloma practice.
Dr. Berenson, your study challenges central issues that newly diagnosed myeloma patients and survivors are led to believe are central to managing our blood cancer. Because I’m a laymen I am going to focus on those treatment issues that I have studied and blogged about previously on PeopleBeatingCancer.com.
I first read the study’s summary posted in several places on the Internet. I decided that I had to read the entire study in order to understand it and write about it on PBC. I then purchased the full study. If you are a myeloma patient trying to learn about your blood cancer I encourage you to read this study.
Those five pillars of conventional myeloma therapy that your study calls into question are as follows:
- Real world results vs. clinical trials
- Standard-of-care in Multiple Myeloma
- Autologous Stem Cell Transplantation in Multiple Myeloma
- High-Risk Disease in Multiple Myeloma
- Five year Survival Rates
Real world results versus clinical trial results-
Newly diagnosed multiple myeloma (NDMM) patients are told that clinical trials are the “gold standard” when it comes to evidence-based medicine. My understanding is that virtually all therapy decisions are based on clinical trials. While your study isn’t openly critical of clinical trials for myeloma, by stating that
“Due to strict eligibility criteria, which prevent the majority of patients from being included in these studies [8], clinical trials’ subjects are not representative of an unselected MM population.”
your study implies that clinical trials can mislead the NDMM patient trying to learn about and understand his/her therapy options.
Standard-of-care in the treatment of multiple myeloma-
The majority of NDMM patients are prescribed the FDA approved, standard-of-care induction regimen of either RVD or D-RVD. Dr. Berenson, your 1, 3 and 5 year survival rates, the common performance metric for all myeloma specialists, are based on treatment regimens that do not follow the FDA approved standard-of-care treatment regimen. I have to wonder if the standard-of-care chemo cocktail is the right choice for newly diagnosed myeloma patients.
Autologous Stem Cell Transplantation and multiple myeloma-
The standard-of-care also includes an autologous stem cell transplant (ASCT). Dr. Berenson, you make a point, in several places in your study, that “no patients underwent an autologous stem cell transplant.” In my past research, I have read your comments about how you believe that an ASCT hurts most MM patients. Again, you achieve the longest aka best results of any MM specialist that I know of without the SOC autologous stem cell transplant.
High-risk disease in multiple myeloma-
According to research “Between 10–20% of people with multiple myeloma die within 2–3 years following diagnosis. People in this subgroup can be classified as having high risk multiple myeloma.” You make a point of showing that your results come from patient spread among all stages- 1,2,3 and with “35% of patients considered high-risk.” Your sample of myeloma patients is a much higher percentage of difficult to treat, high-risk MM patients yet your 5 year average is much longer than other MM specialists.
Five year survival rates-
I know that I’ve mentioned them a couple of time previously. I am fixated on this single issue because all of the above four pillars that I have focused on are reasons why Dr. Berenson has achieved superior five year survival rates. In other words, by following many practices that are not what conventional oncology practices, such as:
- adhere to clinical trial findings
- adhere to standard-of-care practices
- prescribe an ASCT for most NDMM patients
- successfully treat high-risk mm patients
James Berenson achieves better/longer 1,3, and 5 year survival rates.
“The OS reported in this study (median 136.2 months- more than 11 years) is the longest reported to date in an unselected, newly diagnosed MM population.”
James Berenson, myeloma specialist, has called into question everything we’ve been told about conventional oncology’s treatment of multiple myeloma-
Have you been diagnosed with multiple myeloma? Do you have questions about your prognosis, therapy plan, overall survival, etc? Send me a question or a comment and I’ll reply to you ASAP.
David.PeopleBeatingCancer@gmail.com
Hang in there
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Clinical Outcomes and Serum B‐Cell Maturation Antigen Levels in a Real‐World Unselected Population of Newly Diagnosed Multiple Myeloma Patients
Background- Progression-free survival (PFS) and overall survival (OS) of newly diagnosed multiple myeloma (MM) patients have been widely published in the clinical trials setting, but data published from real-world settings are limited…
Objective We determined the survival and factors that predict outcomes among 161 unselected, newly diagnosed MM patients whose frontline therapy was started at a single clinic specializing in the treatment of this B-cell malignancy.
Patients and Methods- None of these patients underwent an autologous stem cell transplantation (ASCT) as part of the initial therapy and the population had a high proportion (35%) of cytogenetic high-risk patients…
The 1-, 3-, and 5-year survival rates were 97.5%, 85.3%, and 76.2%, respectively. These results are considerably better than those reported from patients enrolled in clinical trials and those from countries with national registries. Age <65 years predicted for a longer OS (p = 0.0004)…
Conclusion These results provide clinicians with a real-world understanding of the survival of unselected, newly diagnosed patients initiating therapy in a clinic specializing in the care of MM patients…
Many studies that evaluated outcomes among newly diagnosed MM patients have been conducted in the clinical trials setting. Due to strict eligibility criteria, which prevent the majority of patients from being included in these studies [8], clinical trials’ subjects are not representative of an unselected MM population.
Patients with:
- poor perfor- mance status,
- renal impairment,
- reduced blood counts,
- and more advanced disease
are often not included in these trials. Several studies have shown that patients who are ineligible for clinical trials experience shorter OS [8, 9].
Treatment of MM in an unselected clinical setting involves a heterogenous group of patients due to tumor cell- and bone marrow (BM) microenvironment-related factors, immune status, patient-related characteristics, availability of drugs, and local treatment guidelines, leading to large differences in survival outcomes [10].
Data regarding contemporary treatment patterns and outcomes among newly diagnosed MM patients are limited and this needs to be obtained using real- world data, and more thoroughly investigated to help inform treating healthcare professionals…
PFS was determined from the first day of receiving frontline therapy until progression of disease or censorship, while OS was determined from time of diagnosis of MM until death or censorship…
According to ISS criteria, 60 (37%), 52 (32%), 32 (20%), and 17 (11%) patients were stage I, II, III, and unknown at the start of treatment, respectively. Using R-ISS criteria, 28 (17%), 67 (42%), 19 (12%), and 47 (29%) patients were stage I, II, III, and unknown at start of treatment, respectively.
Of the 78 patients (48%) who had cytogenetic analysis performed, 27 (35%) were high-risk, as defined by the presence of del(17p), t(4;14) and/or t(14;16); 15 and 10 patients showed t(11;14) and a +1q cytogenetic abnormal- ity, respectively…
Among the 43 patients who died, the median number of therapies was 5 (range 1–26). Deceased patients who died before the median date of all deaths (30 December 2018) had a median number of therapies of 4 (range 1–11), whereas those patients who died after that date had more lines of treatment, a median of 6 therapies (range 1–26)…
No patients underwent an autologous stem cell transplantation (ASCT) as part of their frontline treatment regimen, and one patient had an ASCT that was performed during their second treatment…
Patients with R-ISS stages 1, 2, and 3 had median PFS times of 29.4, 24.4, and 9.7 months, respectively (Fig. 9a). PFS was longer for patients having R-ISS stage 1 versus stage 3 (p = 0.0225)…
Patients with R-ISS stages 1, 2, and 3 had median OS lengths of 320.6, 136.2, and 80.0 months, respectively (Fig. 9b) but there were no significant differ- ences between stages…
The primary objective of this retrospective study was to assess the real-world treatment patterns and survival out- comes for unselected, newly diagnosed MM patients treated in a single clinic specializing in their care. The OS reported in this study (median 136.2 months) is the longest reported to date in an unselected, newly diagnosed MM population…
Our study showed that patients who achieved a CR had improved PFS but no improvement in OS, which is in accordance with a few similar studies [26, 27]…
Although the majority of patients were treated with DVD [17], the most common frontline therapy in the US is the combination of lenalidomide, bortezomib, and dexametha- sone (RVD) [34]. A long-term study using this latter combi- nation as induction therapy followed by an ASCT reported a median PFS of 65 months and OS of 126.6 months [34]…
Although the majority of patients were treated with DVD [17], the most common frontline therapy in the US is the combination of lenalidomide, bortezomib, and dexametha- sone (RVD) [34]. A long-term study using this latter combi- nation as induction therapy followed by an ASCT reported a median PFS of 65 months and OS of 126.6 months [34]…
