2023-09-04 13:17:28
María Victoria Mateos, president-elect of the Spanish Society of Hematology and Hemotherapy (SEHH).
70 Spanish hospitals and almost 500 patients is the objective of the most ambitious clinical trial in Hematology developed in Spain in multiple myeloma to date. It is being developed by the group GEM-Pethemaa cooperative research network supported by the Foundation of the same name, under the umbrella of the Spanish Society of Hematology and Hemotherapy (IT’S OKAY). The possibility of leading a multiple myeloma trial of this size 50 years ago was only a dream. A group of specialists dreamed big and today it is a reality. This September 5, World Multiple Myeloma Day, GEM-Pethema Remember that Spain is at the top of the world for research into this disease and that it is working to cure it.
The cutting-edge research carried out by the Spanish Myeloma Group translates into years of life. For the president of the SEHH, Maria Victoria Mateosalso co-coordinator of the GEM, “our cooperative group has carried out very relevant contributions in research in Hematology that have brought innovation closer to Spanish patients and contribute to generating knowledge and scientific evidence, both clinical and biological, through their research work”.
Juan Jose Lahuertaone of the founders of the Pethema Foundation and co-coordinator of GEM-Pethema together with specialists Jesus saint michael, Joan Blade y Maria Victoria Mateosrecalls the beginnings: “The first large GEM study, in patients with Newly Diagnosed Multiple Myeloma (MMND) was the observational Myeloma 2000 protocol. In 2005 we managed to start our first Phase III clinical trial”.
“When we started, at the end of the 1990s, in the patients included in the Spanish Registry of Autologous Transplantation in Multiple Myeloma, the median progression-free survival (SLP) had increased from 15 to 35 months. With the GEM12minus65 trial, PFS has exceeded a median of 80 months and we hope to get closer to a cure in the patients included in our most recent phase III clinical trial”, he underlines.
Results of clinical trials in myeloma
GEM21minus65 happens to Fase III GEM12menos65a clinical trial whose results, -still pending a new evaluation with greater follow-up-, were announced in 2022 at the Plenary Session of the 19th Congress of the International Myeloma Society. GEM12minus65, which included patients with newly diagnosed multiple myeloma (MMND) treated with VRD (bortezomib, lenalidomide and dexamethasone) before and after autotransplantation with melphalan or busulfan, followed by maintenance within the Phase III GEM2014MAIN clinical trial, which compared lenalidomide-dexamethasone vs . lenalidomide-dexamethasone-ixazomib (Rosiñol L et al. Blood 2023) has achieved a Progression Free Survival (PFS) of 80.8 months, the best ever reported, surpassing the 67.5 months that constituted the previous best reference (Richardson PD et al.NEJM 2022). “We hope to offer consolidated results in the coming months,” says Lahuerta.
GEM21menos65, con 62 active centers (70 planned) and 173 patients included (480 programmed) compares combination treatment of VRD extended up to 18 cycles together with a salvage early intervention strategy versus Isatuximab-VRD and versus Isatuximab-V-iberdomide in patients 65 years of age or younger with MMND candidates for autologous heart transplantation. hematopoietic progenitors (Taspe).
GEM-Pethema maintains four other clinical trials in the recruitment phase: GEM-Iberdarax, GEM-Belma, GEM-Rantab and GEM-Tectal. The first, a phase II trial with 140 patients (41 recruited to date), is carried out in 16 centers. Its objective is to evaluate dexamethasone iberdomide alone or in combination with standard multiple myeloma treatment regimens in MMND patients who are not candidates for transplantation.
GEM-Belma is a phase I/II, open-label, multicenter study analyzing the treatment of patients with relapsed and refractory Multiple Myeloma to lenalidomide with belantamab mafodotin in combination with carfilzomib and dexamethasone. In the pre-inclusion phase (phase I) the aim is to determine the maximum tolerated dose and the recommended dose. In phase II the objective is to evaluate the efficacy in terms of complete response rate and negative minimal residual disease rates after 12 months of treatment together with the safety and tolerability of the combination. This trial plans to include 60 patients in 15 Spanish centers.
New recruits in antibody trials
GEM-RANTAB is an open-label, multicenter, Elranatamab Phase II as a single agent for the treatment of relapsed or refractory myeloma in patients previously exposed to three classes of drugs. This trial plans to include 50 patients in 15 Spanish centers. Lastly, the GEM-Tectal, a phase II, open-label, multicenter pilot study to evaluate early intervention with T-cell redirecting bispecific antibodies (teclistamab and talquetamab) in the first-line treatment of newly diagnosed high-risk multiple myeloma. With an objective of 30 patients and the expected participation of 10 centers.
As stressed by the scientific secretary of the Governing Council of Pethema and coordinator of the Spanish Group of Acute Myeloblastic Leukemia (AML-Pethema), Pau Montesinos, “this scientific group is an atypical and outstanding phenomenon in research and care for haematological patients”. “It is proof that with the will and passion of all of us who are part of this group, an academic cooperative network can be developed that covers practically all the hospitals in Spain”, he points out.
Pethema is “a unique instrument in the SEHH. In Spain, there are very few organizations like ours capable of supporting cooperative groups that carry out top-level research”, says Lahuerta.
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