1. Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial
- Author
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Martin Goerner, Markus Munder, Martin Hoffmann, Katja Weisel, Peter Brossart, Elias K. Mai, Anja Seckinger, Hans Salwender, Bernhard Rabold, Dirk Hose, Thomas Hielscher, Igor Wolfgang Blau, Uta Bertsch, Steffen Luntz, Ahmet H. Elmaagacli, Stefanie Huhn, Nicola Giesen, Hartmut Goldschmidt, Jens Hillengass, Marc S. Raab, Christina Kunz, Christof Scheid, Anna Jauch, Maximilian Merz, Diana Tichy, Barbara Hügle-Dörr, Hans-Walter Lindemann, Mathias Hänel, Helga Bernhard, Jan Dürig, Stephan Fuhrmann, Hematology, and Basic (bio-) Medical Sciences
- Subjects
Male ,0301 basic medicine ,Melphalan ,Oncology ,Cancer Research ,Medizin ,Dexamethasone ,Cyclophosphamide/administration & dosage ,Bortezomib ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,Lenalidomide/administration & dosage ,Medicine ,Hematopoietic Stem Cell Transplantation/mortality ,Prospective Studies ,Lenalidomide ,Multiple myeloma ,education.field_of_study ,Maintenance Chemotherapy/mortality ,Remission Induction ,Hazard ratio ,Hematopoietic Stem Cell Transplantation ,Hematology ,Prognosis ,Combined Modality Therapy ,Thalidomide ,Survival Rate ,030220 oncology & carcinogenesis ,Female ,Multiple Myeloma ,medicine.drug ,Dexamethasone/administration & dosage ,Melphalan/administration & dosage ,medicine.medical_specialty ,Population ,Transplantation, Autologous ,Maintenance Chemotherapy ,03 medical and health sciences ,Internal medicine ,Internal Medicine ,Humans ,education ,Cyclophosphamide ,Survival rate ,Aged ,Thalidomide/administration & dosage ,business.industry ,Consolidation Chemotherapy/mortality ,medicine.disease ,Multiple Myeloma/pathology ,Consolidation Chemotherapy ,Transplantation ,030104 developmental biology ,Bortezomib/administration & dosage ,Antineoplastic Combined Chemotherapy Protocols/therapeutic use ,business ,Follow-Up Studies - Abstract
The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.
- Published
- 2020
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