“Clinical trials are the driving force behind most oncology discoveries and FDA approvals; however, strict eligibility criteria restrict many patients from participating, potentially leaving out large groups of people..”
It is standard-of-care for multiple myeloma (MM) patients to undergo low-dose maintanence lenalidomide (revlimid) therapy after an autologous stem cell transplant (ASCT). Newly diagnosed MM patients who are ineligible for an ASCT are prescribed Revlimid (lenalidomide) and Dexamethasone.
According to research, the average multiple myeloma (MM) patient is a 70 year old black male. That means that half of all newly diagnosed MM patients are older than 70 and half of all MM patients are younger than 70. A third of all MM patients are 75 or over. MM is an old person’s disease.
So why do the clinical trials for low-dose Revlimid therapy for MM patients linked below exclude all MM patients under the age of 65? I mean, researchers would understand the age of MM patients, right?
According to the second study linked below, it could be because “Clinical trials are the driving force behind most oncology discoveries and FDA approvals…” If older MMers were added to the study, perhaps the chemotherapy regimen wouldn’t be approved by the FDA???
“Evidence-based” decision-making is the basis for all therapies prescribed to the newly diagnosed MM patient. However, if the FDA approves therapies that are not accurately trialed, or properly tested, how can MM oncology do their job?
If you are newly diagnosed with MM and you are also younger that 65 years of age, the studies linked below should apply to you. I’m not sure but I think all of the MM patients who developed serious side effects from Revlimid therapy were dropped from the clinical trials. So that may concern you…
It is in the interest of newly diagnosed multiple myeloma patients, survivors and caregivers to learn about and pursue all evidence-based MM therapies be they conventional or non-conventional.
Have you been diagnosed with multiple myeloma? Scroll down the page, post a question or comment and I will reply to you ASAP.
Thank you,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Recommended Reading:
“In IFM 2005-02, patients aged < 65 years who had undergone induction therapy followed by autologous stem cell transplant and had achieved at least a stable disease response at the time of hematologic recovery were eligible. Within 6 months after stem cell transplant, patients were randomized to receive either lenalidomide or placebo.
In CALGB 100104, among 231 patients randomized to receive lenalidomide vs 229 randomized to receive placebo, median progression-free survival was 33.9 vs 19.0 months (hazard ratio [HR] = 0.38, P < .001) at unblinding and 68.6 vs 22.5 months (HR = 0.38, 95% confidence interval [CI] = 0.28–0.50) at updated analysis in March 2015.
In IFM 2005-02, among 307 lenalidomide patients vs 307 placebo patients, median progression-free survival was 41.2 vs 23.0 months (HR = 0.50, P < .001) at unblinding and 46.3 vs 23.8 months (HR = 0.53, 95% CI = 0.44–0.64) at updated analysis.
At updated overall survival analysis in February 2016, median overall survival was 111.0 vs 84.2 months (HR = 0.59, 95% CI = 0.44–0.78) in CALGB 100104 and 105.9 vs 88.1 months (HR = 0.90, 95% CI = 0.72–1.13) in IFM 2005-02.
Treatment should be interrupted in patients developing grade 3 or 4 thrombocytopenia (platelet count < 30,000/µL) or neutropenia (absolute neutrophil count < 500/µL) and complete blood cell counts should be followed weekly; upon recovery, treatment should be resumed at a lower dose. Similarly, treatment should be interrupted for other grade 3 or 4 adverse events and resumed at a lower dose upon resolution to grade ≤ 2...”
“Clinical trials are the driving force behind most oncology discoveries and FDA approvals; however, strict eligibility criteria restrict many patients from participating, potentially leaving out large groups of people…
In the myeloma setting, patients tend to be older and with more comorbidities, which often prevents them from enrolling in a trial…
“In general, we’re learning more and more that clinical trials are really important to get drugs approved, but we really do need to balance that with real-world evidence, recognizing the disparities between the 2,” he said.
“We really need to broaden [clinical trial selection criteria], particularly in myeloma where patients are older. They’re going to have other cancers; they’re going to have renal dysfunction. If we’re not allowing these patients [on trials], how do we generalize study data to people we’re actually treating in clinic?””
