Pomalidomide and Low-Dose Dexamethasone Improves Survival for Patients with Multiple Myeloma
Results from a randomized proviso III hearing uncover that a mixed of pomalidomide (Pomalyst®) and low-dose dexamethasone might advantage some patients with mixed myeloma that has worsened (progressed) notwithstanding other treatments. Patients who perceived a mixed therapy lived longer but a illness surpassing (progression-free survival) than patients who perceived high-dose dexamethasone alone. Overall presence was also softened in a organisation that perceived a mixed therapy compared with a other group.
Lancet Oncology, Sep 3, 2013 (See a biography abstract.)
Patients with modernized mixed myeloma whose illness worsens after mixed lines of therapy have few diagnosis options and a bad prognosis. The median presence time for these patients is 9 months.
Previous studies have indicated that pomalidomide might be useful in patients with mixed myeloma that is not responding to other treatments. The drug, a plug taken by mouth, belongs to a category of drugs called immunomodulating agents. Pomalidomide does dual things: first, it helps a bone pith to furnish normal blood cells, and second, it enhances a ability of defence cells to kill aberrant cells in a bone marrow.
On Feb 8, 2013, a Food and Drug Administration (FDA) postulated accelerated capitulation to pomalidomide for a diagnosis of patients with mixed myeloma who perceived during slightest dual before therapies, including lenalidomide (Revlimid®) and bortezomib (Velcade®), and whose illness progressed within 60 days of completing a final therapy.
Several pomalidomide-based studies are underneath way, including a hearing compulsory by a FDA as a condition of accelerated capitulation for a drug. That randomized proviso III clinical hearing (CC-4047-MM-007) is comparing pomalidomide, bortezomib, and low-dose dexamethasone with bortezomib and low-dose dexamethasone in patients with formerly treated mixed myeloma.
The hearing published in Lancet Oncology was designed to review pomalidomide and low-dose dexamethasone and high-dose dexamethasone, that was deliberate a customary diagnosis when a hearing was launched. The researchers incidentally reserved 302 patients to accept pomalidomide and low-dose dexamethasone and 153 to accept high-dose dexamethasone. The participants—from Australia, Canada, Europe, Russia, and a United States—all had modernized mixed myeloma that was inauspicious or both relapsed and refractory. In all cases, a illness had progressed notwithstanding during slightest dual before treatments of bortezomib, lenalidomide, or both.
The primary endpoint of a open-label investigate was progression-free presence (PFS). The pivotal delegate endpoint was altogether survival. Other delegate endpoints enclosed a altogether response rate (the suit of patients who achieved during slightest a prejudiced response), time to progression, and peculiarity of life. Celgene Corporation, a builder of pomalidomide, saved a clinical trial.
After a median follow-up of 10.0 months, a researchers found, patients in a pomalidomide and dexamethasone organisation had lived 4.0 months but a illness worsening, compared with only 1.9 months among a patients reserved to accept high-dose dexamethasone alone. In addition, patients in a pomalidomide organisation lived about 4.6 months longer than patients in a high-dose dexamethasone organisation (12.7 months contra 8.1 months). Furthermore, scarcely one-third of a patients in a pomalidomide organisation (95 of 302 patients) had their tumors cringe or showed other signs of achieving a prejudiced response.
Common side effects in both groups enclosed neutropenia, anemia, and thrombocytopenia. In a pomalidomide group, a side effects were identical to those observed in other trials involving pomalidomide and were mostly manageable; few patients dropped diagnosis since of treatment-related inauspicious events. There were 11 treatment-related inauspicious events heading to genocide in a pomalidomide organisation and 7 in a high-dose dexamethasone group.
“Based on a results, pomalidomide and low-dose dexamethasone could be a diagnosis choice for patients with modernized inauspicious or relapsed and inauspicious mixed myeloma in whom diagnosis with bortezomib and lenalidomide has been unsuccessful,” lead author Jesus San Miguel, MD, of Universidad de Salamanca, Spain, and his colleagues concluded.
A reduction of a investigate was a open-label design, a authors noted. In addition, some patients in a high-dose dexamethasone organisation “crossed over” and began to take a mixed therapy before their illness had progressed, that might have influenced a bulk of a disproportion in altogether presence between a diagnosis groups. Similarly, assessing PFS between a groups was a challenge, since many patients in a high-dose dexamethasone organisation “crossed over” and began to take a mixed therapy after a advantage was evident.
“Based on these data, pomalidomide and low-dose dexamethasone is an critical new further to a diagnosis armamentarium for patients with modernized inauspicious or relapsed and inauspicious mixed myeloma,” commented Ola Landgren, MD, PhD, arch of NCI’s Multiple Myeloma Section. “The anti-myeloma outcome is substantial, and a side-effect form for this fast is really reasonable.”
The formula of this hearing are identical to those of early studies involving pomalidomide, remarkable Xavier Leleu, MD, PhD, of Hopital Huriez, CHRU, Lille, France, in an concomitant editorial.
A successive news will report a outcome of pomalidomide on peculiarity of life, Dr. Leleu continued, “but it seems judicious to assume that a verbal accessibility of pomalidomide, fast conflict of response, increasing abyss of response and enlarged presence will urge a peculiarity of life of patients with inauspicious or relapsed and inauspicious myeloma.”
Additional studies of a drug are underneath approach and should assistance researchers learn how best to build on a stream commentary to advantage patients with this disease, he added. “Pomalidomide can be used in mixed with roughly all existent antimyeloma drugs since of a auspicious reserve profile.”