A recent study published in Blood, looked at Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma (MM). The study, conducted by Paul G. Richardson, et al., was the first report on a landmark treatment regimen for newly diagnosed myeloma patients that for the first time combined lenalidomide and bortezomib.
To carry out this effort required a team approach comprising two competing pharmaceutical companies (joining forces to study this promising regimen) and multiple academic medical centers (AMCs). Together, this team conceived of a winning combination chemotherapy regimen using lenalidomide, bortezomib, and dexamethasone (RVD) in newly diagnosed myeloma patients.
The project was carried out as an open-label phase 1/2 (http://www.ClinicalTrials.gov: NCT00378105) study, which was conducted at 6 centers in the United States, with enrollment between September 13, 2006, and February 18, 2008. The total treated population enrolled was 66 patients.
Accordingly, the study found an unprecedented 100% of patients treated at the defined phase 2 dose level responded to treatment: 74% of patients experienced a 90% reduction in tumor burden and 57% entered a complete remission (CR) within a few months of starting treatment. From these findings, the study concluded that lenalidomide-bortezomib-dexamethasone is a highly effective regimen for previously untreated MM, and may represent the basis of future standards-of-care in this setting.
Following the publication of this breakthrough study, an editorial written by A. Keith Stewart of the Mayo Clinic, was published in August edition of Blood. Stewart asserted from the findings in this study that “there is little doubt that this regimen represents a leap forward in myeloma care and serves as an important platform on which to build.”
Stewart then recognized that “a critical next step building on RVD will be reducing toxicity (one model might be use of weekly bortezomib) and prolonging and maintaining remission through consolidation and maintenance therapy.” He acknowledged that in order to take this next step, that “such advances will require an ongoing team effort, with industry, academia, foundations, and government working together.”
He further added that despite the current “era in which increasing oversight, regulation, and negative media attention threaten to suffocate the interaction of the pharmaceutical industry, academic researchers, and hematologistoncologists:”
“it is refreshing to point to the example of RVD where the significant benefits to patients that result from such positive interactions are apparent.”
As a result, Stewart maintained that “with respect to the future of myeloma trials and to the prerequisite for close industry–physician interaction,” the union between academia and industry “must be preserved.”
Ultimately, the outcome of this study sets a good example and model for future collaboration between industry, government and academia, one which all stakeholders should begin to adopt in many other disease areas immediately.