Further Findings Show Pomalyst plus Low-Dose Dexamethasone Safe and Effective
For patients with relapsed or refractory multiple myeloma, treatment with Pomalyst® (pomalidomide) plus low-dose dexamethasone appears safe and effective.(1) Researchers continue to evaluate the best way to use pomalyst for recurrent myeloma and its inclusion into induction treatment regimens for newly diagnosed individuals.
Pomalyst is an immunomodulatory drug that initially demonstrated activity in multiple myeloma patients who have become refractory to Velcade and Revlimid. It inhibits myeloma cells growth by stopping new blood vessels from forming.
Alone, Pomalyst appears to have only limited activity in multiple myeloma. Previous findings have shown, however, that Pomalyst may be more effective when combined with low-dose dexamethasone, a corticosteroid that may produce anticancer effects by inhibiting inflammatory agents implicated in the development or growth of multiple myeloma.(1,2)
The Phase III STRATUS clinical trial evaluated the safety and efficacy of Pomalyst plus low-dose dexamethasone for patients with relapsed or refractory multiple myeloma. The study enrolled 456 patients, between 37 to 88 years, with a median age of 66 years who had failed previous treatment for multiple myeloma. Seventy-eight percent of patients had disease that had progressed after Revlimid and Velcade.
Pomalyst treatment consisted of 4 mg of Pomalyst on days 1–21 of a 28-day cycle plus low-dose dexamethasone at 40 mg per day (or 20 mg per day for patients older than 75 years) on days 1, 8, 15, and 22 until disease progression or unacceptable side effects. In addition, all patients received low-dose aspirin, heparin (a blood thinner), or an equivalent to prevent blood clots.
Thirty-five percent of patients responded to treatment, with a very good or better partial response among 6%. Overall the average duration of progression-free survival was 4.3 months, and overall survival was 10.9 months. Response lasted for an average of six months.
When researchers evaluated survival for only the patients with disease that was refractory to Revlimid and Velcade, they found that survival was similar to the study overall:
- Progression-free survival of 4.2 months for those refractory to Revlimid and 3.9 months for those refractory to both Revlimid and Velcade
- Overall survival was 10.9 months for all refractory patients
- There was a response rate of 34% for those refractory to Revlimid and 33% for those refractory to both Revlimid and Velcade
The most common side effects for treatment with Pomalyst and low-dose dexamethasone included neutropenia (low count of neutrophils, a type of white blood cell), anemia, thrombocytopenia (low blood platelet count), pneumonia, fatigue, and hypercalcemia (above-normal blood calcium). Doses were reduced in 28% of patients as a result of side effects, and only 9% had to stop treatment as a result of side effects.
Based on these recent findings from the STRATUS trial, Pomalyst and low-dose dexamethasone appears to be an effective and safe treatment for patients with multiple myeloma that has progressed after Revlimid and Velcade. These results are similar to earlier findings, with help establish Pomalyst and low-dose dexamethasone as a new standard of therapy for patients with relapsed or refractory multiple myeloma.
- Dimopoulos MA, Palumbo A, Weisel K, et al. Safety and Efficacy in the Stratus (MM-010) Trial, a Single-Arm Phase 3b Study Evaluating Pomalidomide + Low-Dose Dexamethasone in Patients with Refractory or Relapsed and Refractory Multiple Myeloma. Program and Abstracts of the 56th American Hematological Society Annual Meeting and Exposition; December 6–9, 2014; San Francisco, California. Abstract 80.
- San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncology. Published early online September 3, 2013. doi:10.1016/S1470-2045(13)70380-2
- Dimopoulos MA, Lacy MQ, Moreau P, et al. Pomalidomide in Combination with Low-Dose Dexamethasone: Demonstrates a Significant Progression Free Survival and Overall Survival Advantage, in Relapsed/Refractory MM: A Phase 3, Multicenter, Randomized, Open-Label Study. Blood (ASH Annual Meeting Abstracts) 2012 120: Abstract LBA-6.