Dec 9 2009
The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians— says a large number of abstracts – nearly a quarter of the presentations submitted this year to the annual meeting of the American Society of Hematology (ASH) were for myeloma, with one being presented at the prestigious plenary session. Particularly interesting this year, were a group of studies that may represent important steps forward in the treatment or understanding of the disease from its earliest stages on.
“This has been one of the most exciting medical meetings for myeloma in recent years,” said Susie Novis, president and co-founder of the IMF. “We believe patients with myeloma and related blood cancers will have more treatment options that could lead to a better quality of life.”
SMOLDERING MYELOMA
A phase I/II study of note from Maria-Victoria Mateos, M.D., at the University of Salamanca in Spain, demonstrated for the first time that early intervention treatment before clinical symptoms occur may delay the onset of active myeloma (abstract #614). In the observation-only arm of this randomized study where patients are watched closely but not treated, 50% of patients with high-risk smoldering myeloma progressed to active myeloma in 19 months, including the classic symptoms of bone disease. However, in 45 patients who began and continued active treatment with REVLIMID® at this early stage, no disease progression was observed after a median follow-up of 16 months.
ONGOING ACTIVE THERAPY
A study from Antonio Palumbo, M.D., the University of Torino, Italy, (abstract #613) shows “ongoing active therapy” may be a new option for patients with myeloma. This is the first study to show benefit from continuing treatment as long as the patient continues to respond and may be a first step toward revising current standards of care. The study compared patients treated with a standard combination of melphalan-prednisone (MP), to patients treated with melphalan-prednisone plus REVLIMID (MPR) who remained on ongoing active treatment with REVLIMID (MPR-R). The interim data presented at ASH demonstrated a 77% overall response rate for MPR-R, and a 50% reduction in risk of disease progression versus patients treated with limited duration MP, which is the highest risk reduction reported for any phase III study in this patient group.
The presentation concluded, “MPR-R (ongoing active therapy) can be considered a new standard of treatment for elderly patients.”
Brian G.M. Durie, M.D., chairman and co-founder of the IMF noted, “These interim results are extremely encouraging, and we certainly look forward to further analysis at the next medical meeting as the trial progresses, and potentially adding this as another option as a standard of care.”
VELCADE® COMBINATIONS
At the conference many studies were presented indicating benefits using a wide range of VELCADE combinations. This includes three-drug combinations such as VELCADE-REVLIMID-dexamethasone, VELCADE-cyclophosphamide-dexamethasone, VELCADE-THALOMID-dexamethasone, and the four-drug combination VELCADE-CYTOXAN®-REVLIMID-low dose dexamethasone. It is important to note that the longer-term follow-up of the VELCADE-melphalan-prednisone combination, the VISTA trial, continues to show an overall survival benefit.
“We now have several very active VELCADE combination protocols,” said Dr Durie. “The next step is to sort through these combinations to determine which will confer the best benefit in the short-term and ultimately long-term survival.”
PIPELINE DRUGS AND COMBINATIONS
Some of the most exciting presentations for the future treatment of myeloma are the results of studies of new drugs such as carfilzomib and pomalidomide as single agents or with steroids, combinations that include existing drugs such as VELCADE plus vorinostat, or combinations now using REVLIMID with vorinostat.
Another combination is the randomized study comparing melphalan-prednisone-REVLIMID versus high-dose melphalan with autologous stem cell transplant. These results demonstrate that oral drugs in the MPR arm had a 91% progression-free survival at 12 months, identical to that seen in the transplant arm of the study. This raises the possibility that at some point novel combinations could substitute for autologous stem cell transplant in the myeloma treatment paradigm.
Multiple myeloma is a cancer of cells in the bone marrow that affects production of blood cells and can damage bone. It cannot be cured; however, using new therapies in combination and in sequence can provide the potential for long-term remissions with a good quality of life.
http://www.myeloma.org/