Multiple myeloma clinical trials

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New treatments and clinical trials A lot of research is being conducted to find more effective and less toxic treatments. Many of these treatments are under development and some of the most promising are explained below.

However, until the effectiveness and safety of new therapies has been established and demonstrated, are usually only used in cases where the disease has not experienced any remission or patients with relapse after several conventional treatments.

The best way and the most safe to receive a drug or a new treatment is always part of an approved clinical trial. It is important to understand that not all patients are candidates for a new treatment in the development phase, but if the patient is interested in following one of those treatments you will need to discuss it with your specialist.

Clinical trials are planned research involving patients who test new treatments, or compare different types of application of existing treatments. Clinical studies always work under very strict rules that are called Protocol.

All patients taking part in the study are strictly controlled, and the information that is collected through all phases of the study are combined and then analyzed by researchers. The results will help determine which are the best treatments and this way is able to improve the treatment of future patients.

Among the new treatments, one of the most promising is that used a drug called Revlimid. The results of studies that have used REVLIMID ® have been very positive to date by what has already been approved its use.
multiple myeloma clinical trialsOther types of treatment that are being developed are those that include monoclonal antibodies, which are used with the intention to attack the mielomatosas cells without affecting normal cells vaccines which seek to increase the strength of the immune system to attack myeloma; as well as targeted radiation therapy, which aims to eliminate cells mielomatosas with direct application of radiation without affecting other areas of the body.

Many new combinations of drugs, such as for example the CTD (cyclophosphamide, thalidomide and dexamethasone) combined or the combination T-Dex (thalidomide and dexamethasone) are already used. New combinations incorporating VELCADE and REVLIMID to standard treatments are also using.

As for transplants, research right now on the effectiveness of a type of allogeneic stem cell transplant called mini-trasplante, also known as with reduced intensity conditioning allogeneic transplant. It aims to achieve the same effect but with lower than with conventional allogeneic transplantation risks.

Another technique of transplantation is investigating is autologous tandem, which is carried out a second autologous transplant as soon as the patient recovers from the first to increase the level of response and extend to the maximum possible period of remission of the disease.

Since both approaches to treatment are relatively new and have not even evaluated fully, the only way to carry them out is within the context of a clinical trial in a hospital where staff have extensive experience in this type of transplant.

Unfortunately not all new treatments are better than the treatments already existing and proven, so it is essential carried out always intense trials to quite analyze all details of each new treatment.

At the same time, the fact that propose a patient participate in a new clinical trial does not necessarily mean that it is proposing you participate in a new treatment. The study may be testing simply new ways of using already established treatments. In some hospitals, the inclusion of clinical trials in cancer patients is a part of routine practice.

As you are discovering new data on these experimental treatments, his role next to established treatments will be clearer. Eventually, if they prove to be more effective or safer, you can get to replace some of the existing treatments.

New therapeutic advances against multiple myeloma
According to a phase III multi-center clinical trial, led by Dr. Jesús San Miguel, medical director of the University Clinic of Navarra and clinical medicine and translational research at the University of Navarra

The results of the research – 768 patients developed and promoted by the pharmaceutical company Novartis – have been recently published in The Lancet Oncology, one of the journals with the greatest impact in Oncology

The combined use of the drug panobinostat (bortezomib and dexamethasone) conventional treatment in patients with multiple myeloma has shown a significant increase in the rate of disease progression-free survival.

Thus reveal it the results of a multicenter clinical trial phase III carried out 768 led multiple mieloma patients by doctor Jesús San Miguel, medical director of the University Clinic of Navarra and director of clinical medicine and translational research at the University of Navarra. 215 hospitals in 34 countries they have participated in this research.

The findings of the research – which started in 2010 and promoted by the pharmaceutical Novartis – have recently been published in the latest issue of The Lancet Oncology, one of the scientific journals of higher impact specialty.

The conclusions of this clinical trial show a “statistically significant and clinically relevant” 4 months increase in median survival free of disease progression, thus passing from 8.1 to 12 months. The median is the time frame in which continue living half of the individuals studied.

The study has been conducted in patients with multiple myeloma relapsing or relapsed / refractory (that continues to progress during treatment), who were treated with the compound experimental panobinostat (LBH589), combined with bortezomib and dexamethasone.

This therapy was compared in the clinical trial with placebo administration over the same combination of these two drugs.

In the trial phase III, called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA), LBH589 adding also “produced clinically significant increases in full and almost complete response rates and the duration of response”.

The effect of the panobinostat or LBH589 was observed in all subgroups of patients, including high risk cytogenetic and those in advanced stage of the disease.

Multiple myeloma is still an incurable in the majority of patients, with a high rate of recurrence (cancer returns) and resistance (the treatment stops working) hence the importance of the discovery of new drugs. Patients tend to be older than 60 years, few cases occur in people under 40.

Taking into account that the majority of patients with multiple myeloma relapse and become resistant to treatment, “the new therapies with innovative mechanisms of action are fundamental to continue treating the disease and improve outcomes,” stresses Dr. San Miguel. If approved, LBH589 will be the first anticancer agent in its class (acetylases inhibitors) available for this population.

“The PANORAMA-1 study is the first phase III trial which demonstrated the superiority of LBH589 combined with bortezomib and dexamethasone, against the usual regimen of two drugs in patients with multiple myeloma in relapsed or refractory,” announced the principal investigator of the study.

“These results show that, by adding a new mechanism of action, inhibiting bread-DAC, produced a significant benefit in this patient population”, highlights the specialist.

“The majority of people suffering from multiple myeloma stop responding to treatment or relapse, which sharpens the need for new treatment options,” he points out. “The PANORAMA-1 test results provide strong evidence of the potential impact that could have LBH589 on multiple myeloma community”.

In the view of PANORAMA-1 data, LBH589 received preferential designation from the U.S. Food and Drug Administration (FDA) in May and requested its authorization to the European Medicines Agency (EMA).

Currently there are requests regulatory underway around the world. The FDA priority designation is awarded to treatments that offer major advances in treatment.

The trial scene-1

The PANORAMA-1 trial is a randomized trial of phase III, double blind, placebo-controlled multicenter, for the purpose of registration that was designed to analyze the results of LBH589 administration in combination with bortezomib and dexamethasone, compared with the single treatment with bortezomib and dexamethasone in patients with multiple myeloma relapsing or refractory with in at least one prior treatment failure and relapse.

The primary objective of the test was (SLP) progression-free survival. Overall survival, the key secondary objective of the trial data, require more follow-up. Other secondary endpoints were overall response rate, duration of response and safety.

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