Posted on January 26th, 2015 by
For patients with relapsed or refractory multiple myeloma, treatment with Pomalyst® (pomalidomide) plus low-dose dexamethasone appears safe and effective. These findings were presented at the 56th American Hematological Society Annual Meeting and Exposition, December 6–9, 2014, in San Francisco, California.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. In the United States, approximately 70,000 people are living with multiple myeloma and approximately 24,000 new individuals are diagnosed annually. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. There is no standard treatment for patients with multiple myeloma that has become refractory—or resistant—to the drugs Revlimid® (lenalidomide) and Velcade® (bortezomib); these patients have limited treatment options and typically have a poor prognosis.
Pomalyst is an immunomodulatory drug that has shown 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. It is intended for patients who have received at least two prior therapies and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed or refractory).
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 some cancers.
Researchers with the Phase III STRATUS trial sought to further evaluate the safety and efficacy of Pomalyst plus low-dose dexamethasone for patients with relapsed or refractory multiple myeloma. The study, which enrolled 456 patients, was conducted at more than 85 sites across Europe. Patients ranged in age from 37 to 88 years, with a median of 66 years. They had been diagnosed with multiple myeloma as recently as less than one year to 32 years before the study and had received a median of five prior treatments. Seventy-eight percent of patients had disease that had progressed after Revlimid and Velcade.
Of the 456 patients enrolled in the study, 452 had received Pomalyst and low-dose dexamethasone as of a March 2014 follow-up. Treatment included 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.
Among patients overall, media progression-free survival was 4.3 months, and median overall survival was 10.9 months. Thirty-five percent of patients responded to treatment, with a very good or better partial response among 6%. Response lasted for a median 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:
The most common moderate 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
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