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Myeloma Clinical Trials- Exclusion Criteria

Multiple Myeloma First Line Treatment
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What is the purpose of myeloma clinical trials? Exclusion criteria virtually guarantees that the results do not mirror real world experience. And therefore newly diagnosed MM patients will learn little if anything based on clinical trials.

MM is a cancer of the elderly. The average age of newly diagnosed MM patient is 70. Further, African Americans are twice as likely to be diagnosed with MM than whites.

Yet research shows that there are few, if any elderly patients or minorities who participate in  myeloma clinical trials.

I am a long-term MM survivor. I enrolled in two clinical trials when I was undergoing active treatment in ’94 and ’95. My thinking was that my time was limited (3-5 years average survival at the time) and my participation in myeloma clinical trials would benefit future NDMM patients. I was wrong.

What are the pros and cons of myeloma clinical trials?


  1. Access to Innovative Treatments: Clinical trials often test new drugs or treatment approaches that are not yet available to the general public. By participating, you may have access to cutting-edge therapies that could potentially be more effective than standard treatments.
  2. Contribution to Medical Research: By enrolling in a clinical trial, you are contributing to the advancement of medical knowledge and the development of better treatments for myeloma. Your participation may help future patients with myeloma receive improved care.
  3. Comprehensive Care: Clinical trials usually involve close monitoring by medical professionals who specialize in myeloma. This can result in comprehensive care and frequent check-ups, potentially leading to earlier detection of any issues and better overall management of the disease.
  4. Financial Assistance: Many clinical trials cover the costs of the experimental treatment, as well as some of the associated medical expenses. This can help alleviate the financial burden of managing myeloma.


  1. Uncertainty: Since clinical trials are designed to test new treatments, there may be uncertainties about the effectiveness and safety of the experimental intervention. There is a possibility that the new treatment may not work as well as expected or could have unexpected side effects.
  2. Stricter Eligibility Criteria: Clinical trials often have specific eligibility criteria that participants must meet. This can limit the number of individuals who are eligible to participate, potentially excluding some patients who may benefit from the experimental treatment.
  3. Increased Time and Commitment: Participation in a clinical trial may require more time and commitment than standard treatment. This can include more frequent visits to the clinic, additional tests and procedures, and adherence to strict protocols, which may be challenging for some patients.
  4. Potential Side Effects: As with any medical treatment, there is a risk of experiencing side effects or complications from the experimental therapy. These side effects may be unknown or more severe than those associated with standard treatments.
  5. Placebo Control: In some clinical trials, participants may be randomized to receive either the experimental treatment or a placebo (inactive substance). This means that there is a chance you may not receive the active treatment being tested, which can be disappointing for some patients.

There may be different reasons for funding a myeloma clinical trial. That’s  fine. But patient education is a bare minimum in my thinking. Especially if oncology wants to increase patient participation in clinical trials.

When my doctor asked me to participate in the two clinical trials I mention above, there was no discussion of

  • exclusion criteria or
  • potential side effects

I distinctly remember thinking that there was little downside to participating in clinical trials. Was I simply ignorant? Naive? I believe that most NDMM patients who participate in a myeloma clinical trial do so for the following two reasons:

  • Altruistic intentions
  • Access to innovative treatments

I’m curious to hear what you think. Are you a newly-diagnosed myeloma patient? Are you considering participating in a myeloma clinical trial?

What are your thought? Pros, cons?

If you’d like to learn more about both conventional and non-conventional myeloma therapies email me at David.PeopleBeatingCancer@gmail.com

Thank you.

David Emerson

  • MM Survivor
  • MM Cancer Coach
  • Director PeopleBeatingCancer

The Ins and Outs of Inclusion Criteria for Myeloma Clinical Trials

“Clinical trial protocols often incorporate strict eligibility criteria to maximize reproducible, results with minimal risk to trial participants. Unfortunately, restricting a trial’s patient population may result in outcomes that are not generalizable to “real-world” patients, according to a report published in Clinical Lymphoma, Myeloma & Leukemia…

In the Connect MM Registry study, Jatin J. Shah, MD, of the Department of Lymphoma/Myeloma at the MD Anderson Cancer Center in Houston, Texas, and co-authors reviewed eligibility criteria of recent randomized, controlled trials (RCTs) of patients with newly diagnosed myeloma to determine whether the criteria were too strict, and whether the populations enrolled accurately reflected their real-world counterparts…

To identify common eligibility criteria, the authors searched PubMed for phase III myeloma clinical trials conducted in the past 10 years, including studies of thalidomide, lenalidomide, and bortezomib…

The authors found 24 RCTs, all of which had the following exclusion criteria:

  • absence of measurable disease
  • grade >2 peripheral neuropathy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 3 or 4
  • a history of myelodysplastic syndromes, other hematologic malignancies, or solid tumors

Applying these common criteria to the unselected Connect MM Registry, 563 (40%) of the patients would be considered ineligible for RCTs. If exclusion criteria were more aggressive, to include M-protein (≤1.0 g/dL) and hemoglobin (≤8 g/dL) criteria, as many as 56.8 percent of patients would be ineligible for inclusion…

The researchers then compared patient characteristics between those who were RCT-ineligible (n=563) and those who were RCT-eligible (n=843). Significantly more RCT-ineligible patients had

  • hypercalcemia (11.0% vs. 5.5%; p<0.001),
  • creatinine levels >2.0 mg/dL (38.9% vs. 6.2%; p<0.001), and
  • low hemoglobin levels (59.5% vs. 39.5%; p<0.001).






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