Lenalidomide Pharmacokinetics and Bioequivalence in Chinese Multiple Myeloma Patients: What the Study Shows
Multiple myeloma (MM)—an incurable blood cancer that affects plasma cells in the bone marrow—impacts over 100,000 people in China each year, with incidence rising as the population ages. For many patients, lenalidomide (marketed as Revlimid®) is a first-line treatment that can extend survival—but the brand-name drug’s high cost creates barriers to access. To address this, researchers at Sichuan University recently tested a generic lenalidomide capsule to see if it works as well as the original, while also exploring how age influences the drug’s behavior in Chinese MM patients.
What the Study Tested
The 2022 study, published in the Chinese Medical Journal, was led by Tiantao Gao (Clinical Trial Center, West China Hospital) and Xinghong Liu (Department of Medicinal Natural Products, West China School of Pharmacy). It aimed to:
- Compare the bioequivalence (how similarly the body absorbs, uses, and eliminates a drug) of a generic lenalidomide 10 mg capsule (made by Chongqing LUMMY Pharmaceutical Co.) to Revlimid®.
- Examine how age affects lenalidomide’s pharmacokinetics (PK)—key metrics like how quickly the drug reaches peak concentration (Cmax), how long it stays in the body (AUC, area under the plasma concentration-time curve), and its half-life.
The study followed a rigorous multicenter, randomized, two-period crossover design—meaning 39 Chinese MM patients (aged 41–67, with an average age of 53) took both the generic and brand-name drugs in different sequences, with a 3-day “washout” period between doses. Patients fasted for 10 hours before taking the drug, and blood samples were collected at 11 time points (from 20 minutes to 24 hours post-dose) to measure lenalidomide levels.
All procedures complied with the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines and the Declaration of Helsinki, and the study was registered at the Chinese Clinical Trial Registry (CTR20150620).
The Generic Lenalidomide Worked as Well as Revlimid®
The results were clear: The generic lenalidomide was bioequivalent to Revlimid®. Key PK parameters were nearly identical between the two drugs:
- Peak concentration (Cmax): 230 ng/mL (generic) vs. 236 ng/mL (Revlimid®), both reached within 1 hour.
- Total exposure (AUC): 846 ng·h/mL (generic) vs. 873 ng·h/mL (Revlimid®)—a difference well within the 80–125% range the FDA and other agencies use to define bioequivalence.
- Half-life: ~3 hours for both drugs, meaning the body eliminates half the dose in 3 hours.
The 90% confidence intervals (CIs) for Cmax (92.4–106.3%), AUC from 0 to last measurable concentration (94.98–100.16%), and AUC from 0 to infinity (95.2–100.17%) all fell within the acceptable range. For patients, this means the generic is just as effective as the brand-name drug—with the potential to cut costs significantly.
Age Matters: Older Patients Have Higher Drug Exposure
A surprising finding? Age strongly influences how the body processes lenalidomide. When researchers compared AUC (total drug exposure) to patient age, they found a significant positive correlation: Older patients had higher plasma levels of lenalidomide. For example:
- A 65-year-old patient might have 30% higher exposure than a 50-year-old patient taking the same dose.
This aligns with a 2010 study of Japanese MM patients (average age 64), where lenalidomide exposure was higher than in the Chinese cohort (average age 53). The link between age and exposure is critical because MM is more common in older adults—and higher exposure can increase side effects without improving efficacy.
Real-world research supports this: A 2017 study of MM patients over 65 found lower-dose lenalidomide worked just as well as higher doses, with fewer side effects. Another 2018 study (called RVD-lite) confirmed that reduced-dose lenalidomide plus bortezomib and dexamethasone was effective and less toxic for elderly patients. For clinicians, this means age should guide dosing: Older MM patients may need lower lenalidomide doses to avoid unnecessary toxicity.
Is the Generic Lenalidomide Safe?
Yes—both the generic and brand-name drugs were well-tolerated. Of the 39 patients:
- 23% experienced mild adverse events (AEs), including increased D-dimer (a blood clot marker), low white blood cells (leucopenia), or low neutrophils (a type of immune cell).
- All AEs were manageable with supportive care (e.g., dose adjustments, monitoring).
- One patient had a serious AE (fever), but it was unrelated to the drug—attributed to advanced MM.
These findings match what’s known about lenalidomide’s safety profile: Most side effects are mild, and serious issues are rare.
What This Means for Chinese MM Patients
The study delivers two game-changing takeaways:
- Generic lenalidomide is a viable alternative: For patients struggling to afford Revlimid®, the generic capsule (made by Chongqing LUMMY) offers the same benefits at a lower cost.
- Age affects lenalidomide dosing: Clinicians should consider a patient’s age when prescribing lenalidomide—older adults may need lower doses to balance efficacy and safety.
For a disease where first-line treatment is make-or-break, these findings could improve access to care and reduce harm for thousands of Chinese MM patients.
The Bottom Line
This study confirms that generic lenalidomide is bioequivalent to Revlimid® in Chinese MM patients—and highlights age as a key factor in drug exposure. For patients, it’s a step toward more affordable, personalized care. For clinicians, it’s a reminder to tailor lenalidomide doses to each patient’s age and health.
The original study was published in the Chinese Medical Journal in 2022 (Gao et al.). You can find the full research at doi.org/10.1097/CM9.0000000000001695.
References:
- Yong K, et al. Multiple myeloma: patient outcomes in real-world practice. Br J Haematol 2016;175:252–264. doi: 10.1111/bjh.14213.
- Iida S, et al. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol 2010;92:118–126. doi: 10.1007/s12185-010-0624-7.
- Chen N, et al. Clinical pharmacokinetics and pharmacodynamics of lenalidomide. Clin Pharmacokinet 2017;56:139–152. doi: 10.1007/s40262-016-0432-1.
- Nakaya A, et al. Realistic lenalidomide dose adjustment strategy for transplant-ineligible elderly patients with relapsed/refractory multiple myeloma: Japanese real-world experience. Acta Haematol 2017;138:55–60. doi: 10.1159/000477792.
- O’Donnell EK, et al. A phase 2 study of modified lenalidomide, bortezomib and dexamethasone in transplant-ineligible multiple myeloma. Br J Haematol 2018;182:222–230. doi: 10.1111/bjh.15261.
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