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High Risk Smoldering Myeloma Clinical Trial

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You decided to enter a high-risk smoldering myeloma clinical trial. You were told that you were high-risk SMM (HR-SMM) and that chemotherapy may slow or even prevent your progress to full multiple myeloma.

Two key questions- 

  1. Would you join the HR-SMM clinical trial if you could reduce your risk of a MM diagnosis?
  2. Would you join the HR-SMM clinical trial if you were not high-risk SMM?

Reducing the risk of a MM diagnosis-

MGUS and SMM are forms of pre-cancer, not cancer. Therefore, there are no FDA approved therapies for either MGUS or SMM. Most oncologists don’t actively treat MGUS or SMM.

However, there are a number of evidence-based, non-conventional therapies that research has shown can reduce the risk of both MGUS and SMM processing to full MM. Further, undergoing these preventative therapies (exercise, diet, supplementation, etc.) “prehabilitates” the SMM patient.

According to research, prehabilitation enables the patient to respond better to therapy, experience fewer side effects and heal faster.

When I was originally diagnosed, my oncologist told me that I had a single plasmacytoma of bone (SPB). My pathologist told me that I had multiple myeloma. Pre-myeloma diagnoses are tricky. As far as I know, both my oncologist as well as my pathologist were well-educated, experienced medical professionals.

But one of them was wrong.

What are the pros and cons of entering a smoldering multiple myeloma clinical trial?


  1. Access to Cutting-Edge Treatments: Clinical trials often involve experimental treatments or therapies that may not yet be available outside of the trial. By participating, you gain access to potentially groundbreaking approaches that could be more effective than standard treatments.
  2. Close Monitoring and Care: Clinical trials typically involve frequent monitoring by medical professionals who specialize in the condition being studied. This means you’ll receive close attention and care throughout the trial, which can be beneficial for managing your condition.
  3. Contribution to Medical Knowledge: By participating in a clinical trial, you contribute valuable data that helps researchers better understand the disease and develop improved treatments for future patients. Your involvement could potentially benefit others with smoldering multiple myeloma in the long run.
  4. Potential for Personal Benefit: While not guaranteed, there’s a chance that the experimental treatment being tested in the trial could provide significant benefits for you, such as slowing the progression of the disease or improving your quality of life.


  1. Uncertainty: Because clinical trials involve experimental treatments, there’s a level of uncertainty regarding their effectiveness and potential side effects. You may be receiving a treatment that hasn’t been thoroughly tested yet, which could pose risks to your health.
  2. Potential Side Effects: All medications and treatments carry the risk of side effects, and experimental treatments may have unknown or unexpected side effects that could be more severe than those of standard treatments.
  3. Additional Burden: Participating in a clinical trial often requires additional time and effort for frequent medical visits, tests, and procedures. This can be physically and emotionally taxing, especially if you’re already dealing with the challenges of managing a chronic illness like smoldering multiple myeloma.
  4. No Guarantee of Benefit: While there’s potential for personal benefit from participating in a clinical trial, it’s important to remember that there are no guarantees. The experimental treatment may not work for you, and there’s a possibility that you could experience adverse effects without experiencing any improvement in your condition.

So what is the patient considering a high-risk smoldering myeloma clinical trial to do? If there is one thing I’ve learned since my diagnosis of MM, undergoing evidence-based therapies non-conventional therapies shown to fight MM is a good step when a person is diagnosed with pre-Myeloma.

According to the study linked and excerpted below, diagnosing HR-SMM is difficult. The risk models used in the study below disagreed with each other.

Have you been diagnosed with high risk smoldering multiple myeloma? If you would like to learn more about evidence-based non-conventional therapies shown to reduce the risk of a MM diagnosis email me at David.PeopleBeatingCancer@gmail.com

Good luck,

David Emerson

  • MM Survivor
  • MM Cancer Coach
  • Director PeopleBeatingCancer

Assessment of Discordance Among Smoldering Multiple Myeloma Risk Models

“Smoldering multiple myeloma (SMM) is a plasma cell disorder with the potential to evolve to multiple myeloma.1 Several risk stratification models—commonly,

  • the Mayo Clinic Risk Stratification Model 2008,
  • the Programa para el Tratamiento de Hemopatias Malignas (PETHEMA) model, and
  • the newer Mayo Clinic Risk Stratification Model 2018—

have been developed to prognosticate the risk of progression.2,3These models use clinical variables of disease burden rather than biological tumor characteristics to predict

  • low risk (LR),
  • intermediate risk (IR), and
  • high risk (HR) for progression to multiple myeloma (MM).

Multiple clinical trials are investigating the role of treatment in HR SMM. Interpreting the results of clinical trials investigating the role of treatment in HR SMM is problematic owing to variation in the risk stratification criteria used.4 Our study attempts to assess the concordance of these 3 models in a cohort of patients with SMM from 2 clinical trials…


The medical records of 145 patients were reviewed, and patients’ risk was stratified according to the 3 models. Baseline patient characteristics included mean (range) age of 66 (40-91) years, and 84 (57.9%) were male; 109 (75.2%) were White, 32 (22.1%) were Black, and 3 (2.1%) were Asian.

The isotype was IgG, 103 (71.0%); IgA, 34 (23.4%); and light chain, 8 (5.5%); the median M protein, percent plasmacytosis, serum free light chain ratio, and percent aberrant plasma cells (flow cytometry) was 1.3 g/dL, 18%, 9.1, and 97%, respectively.

A total of 101 patients (69.7%) had immunoparesis; 38 patients (26.2%) had 1 and 60 patients (41.4%) had 2 normal immunoglobulin isotypes depressed.

Overall, 42 (29.0%) and 72 (49.7%) patients had agreement in risk stratification across LR, IR, and HR categories among the 2008 and 2018 Mayo Clinic models and the PETHEMA model, respectively (Table).

The overall global rate of agreement across all 3 models for all 3 categories was 16.6%.

Of the 145 patients evaluated, 24 patients were categorized in the same risk group using all 3 models. There was a significant difference in the rates of LR, IR, and HR among the 3 models (Figure, A).

Stratifying HR patients is most important in terms of patient monitoring and enrollment into clinical trials. Therefore, discordance across models in detecting HR patients compared with all others (non-HR) was specifically examined. The ability of models to classify patients as HR vs non-HR was significantly different (Figure, B)…”

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