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SMM – Chemo vs. Observation Trial
“The frequency of second primary malignancies was higher in patients in the treatment group than in those in the observation group (six [10%] of 62 patients vs one [2%] of 63 patients)”
You have been diagnosed with a form of pre-myeloma. Smoldering multiple myeloma (SMM) to be specific. You worry that you will be diagnosed with full-blown multiple myeloma (MM) someday. A growing number of studies talk about diagnostic information that can help you determine your RISK of MM.
Your oncologist encouraged you to participate in a clinic trials to evaluate if active treatment will help you. What does “help you” mean in this case? I will break down what the research says.
“The standard of care for smouldering multiple myeloma is observation”
Conventional oncology has never considered any formal treatment for SMM other than observation.
“The primary endpoint was time from randomisation to progression to symptomatic myeloma”
The trial is seeing if chemo will slow the patient’s progress to a full-blown MM diagnosis.
“Progression to multiple myeloma occurred in 53 (86%) of 62 patients in the observation group compared with 22 (39%) of 57 patients in the treatment group.”
Chemo, in fact, slows a full-blown MM diagnosis if the patient has SMM.
“median overall survival from the time of study entry had not been reached in either group”
The study did not measure “overall survival” of SMM patients who had chemo. OS is length of life.
More than a third of patients in the chemo treatment group experienced side effects including one death and six chemotherapy-induced secondary cancers…
And those are just the serious side effects. The study didn’t track minor side effects like nausea, constipation or diarrhea. Just grade 3 problems, death and second cancers caused by chemotherapy.
The bottom line is that chemo can slow a diagnosis of MM. Chemo will not prevent MM completely, just slow it. And for that you will experience side effects and possibly a second cancer.
To Learn More About Smoldering Multiple Myeloma- click now
To learn about evidence-based nutrition, supplementation and lifestyle therapies that can reduce the risk of MM, 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
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Lenalidomide plus dexamethasone versus observation in patients with high-risk smouldering multiple myeloma (QuiRedex): long-term follow-up of a randomised, controlled, phase 3 trial
“Background: The standard of care for smouldering multiple myeloma is observation. We did the QuiRedex study to compare early treatment with lenalidomide plus dexamethasone with observation in patients with high-risk smouldering multiple myeloma. Here we report the long-term follow-up results of the trial…
Patients in the treatment group received nine 4-week induction cycles (lenalidomide 25 mg per day on days 1-21, plus dexamethasone 20 mg per day on days-1-4 and days 12-15), followed by maintenance therapy (lenalidomide 10 mg per day on days 1-21 of each 28-day cycle) up to 2 years. Group allocation was not masked from study investigators or patients.
The primary endpoint was time from randomisation to progression to symptomatic myeloma…
Lenalidomide plus dexamethasone continued to provide a benefit on time to progression compared with observation (median time to progression not reached vs 23 months [16-31];
Progression to multiple myeloma occurred in 53 (86%) of 62 patients in the observation group compared with 22 (39%) of 57 patients in the treatment group.
At data cutoff, ten (18%) patients had died in the treatment group and 22 (36%) patients had died in the observation group; median overall survival from the time of study entry had not been reached in either group…
The most frequently reported grade 3 adverse events in patients given lenalidomide plus dexamethasone were
- infection (four [6%]),
- asthenia (four [6%]),
- neutropenia (three [5%]), and
- skin rash (two [3%]);
- second primary malignancies (six [10%])
these events all occurred during induction therapy. No grade 4 adverse events occurred, but one (2%) patient in the lenalidomide plus dexamethasone group died from a respiratory infection during induction therapy
The frequency of second primary malignancies was higher in patients in the treatment group than in those in the observation group (six [10%] of 62 patients vs one [2%] of 63 patients)..”
Early or deferred treatment of smoldering multiple myeloma: a meta-analysis on randomized controlled studies
“Smoldering multiple myeloma (SMM) is a rare asymptomatic plasma cell disorder. Even with emerging therapeutic approaches and risk stratification, the optimal time to treat SMM remains controversial. This meta-analysis aimed to compare early treatment with deferred treatment of SMM, especially high-risk SMM…
Results- Eight RCTs covering 885 SMM patients were included. Considering all the different treatment approaches, early treatment significantly decreased progression of SMM. In subgroup analysis, melphalan plus prednisone ) and immuno-modulatory drugs significantly reduced progression.
However, neither mortality nor response rate was significantly affected by early treatment. In terms of high-risk SMM patients, early treatment significantly decreased both progression and mortality.
Frequently seen adverse events were:
- infection,
- constipation,
- asthenia,
- and second primary malignancy.
A remarkably elevated risk of constipation was associated with early treatment using immuno-modulatory agents. Second primary malignancy was significantly increased with early treatment. No significant difference was identified in infection or asthenia.
Conclusion- These findings suggest that early treatment could decrease progression and mortality of high-risk SMM patients with a tolerable safety profile.”