Multiple Myeloma Treatment in Real-world Clinical Practice : Results of a Prospective, Multinational, Noninterventional Study

Funding Information: The authors would like to thank all patients and their families and all the EMMOS investigators for their valuable contributions to the study. The authors would like to acknowledge Robert Olie for his significant contribution to the EMMOS study. Writing support during the development of our report was provided by Laura Mulcahy and Catherine Crookes of FireKite, an Ashfield company, a part of UDG Healthcare plc, which was funded by Millennium Pharmaceuticals, Inc, and Janssen Global Services, LLC. The EMMOS study was supported by research funding from Janssen Pharmaceutical NV and Millennium Pharmaceuticals, Inc. Funding Information: The authors would like to thank all patients and their families and all the EMMOS investigators for their valuable contributions to the study. The authors would like to acknowledge Robert Olie for his significant contribution to the EMMOS study. Writing support during the development of our report was provided by Laura Mulcahy and Catherine Crookes of FireKite, an Ashfield company, a part of UDG Healthcare plc, which was funded by Millennium Pharmaceuticals, Inc, and Janssen Global Services, LLC. The EMMOS study was supported by research funding from Janssen Pharmaceutical NV and Millennium Pharmaceuticals, Inc. Funding Information: M.M. has received personal fees from Janssen, Celgene, Amgen, Bristol-Myers Squibb, Sanofi, Novartis, and Takeda and grants from Janssen and Sanofi during the conduct of the study. E.T. has received grants from Janssen and personal fees from Janssen and Takeda during the conduct of the study, and grants from Amgen, Celgene/Genesis, personal fees from Amgen, Celgene/Genesis, Bristol-Myers Squibb, Novartis, and Glaxo-Smith Kline outside the submitted work. M.V.M. has received personal fees from Janssen, Celgene, Amgen, and Takeda outside the submitted work. M.C. reports honoraria from Janssen, outside the submitted work. M. B. reports grants from Janssen Cilag during the conduct of the study. M.D. has received honoraria for participation on advisory boards for Janssen, Celgene, Takeda, Amgen, and Novartis. H.S. has received honoraria from Janssen-Cilag, Celgene, Amgen, Bristol-Myers Squibb, Novartis, and Takeda outside the submitted work. V.P. reports personal fees from Janssen during the conduct of the study and grants, personal fees, and nonfinancial support from Amgen, grants and personal fees from Sanofi, and personal fees from Takeda outside the submitted work. W.W. has received personal fees and grants from Amgen, Celgene, Novartis, Roche, Takeda, Gilead, and Janssen and nonfinancial support from Roche outside the submitted work. J.S. reports grants and nonfinancial support from Janssen Pharmaceutical during the conduct of the study. V.L. reports funding from Janssen Global Services LLC during the conduct of the study and study support from Janssen-Cilag and Pharmion outside the submitted work. A.P. reports employment and shareholding of Janssen (Johnson & Johnson) during the conduct of the study. C.C. reports employment at Janssen-Cilag during the conduct of the study. C.F. reports employment at Janssen Research and Development during the conduct of the study. F.T.B. reports employment at Janssen-Cilag during the conduct of the study. The remaining authors have stated that they have no conflicts of interest. Publisher Copyright: © 2018 The AuthorsMultiple myeloma (MM) remains an incurable disease, with little information available on its management in real-world clinical practice. The results of the present prospective, noninterventional observational study revealed great diversity in the treatment regimens used to treat MM. Our results also provide data to inform health economic, pharmacoepidemiologic, and outcomes research, providing a framework for the design of protocols to improve the outcomes of patients with MM. Background: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. Patients and Methods: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. Results: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide. Conclusion: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits.publishersversionPeer reviewe

"Spongy, slimy, cosy & more" - Commemorative Volume in Celebration of the 60th Birthday of Joachim Reitner

This volume contains papers presented in part at a symposium held in May 2012 at Göttingen University, to honour Professor Joachim Reitner for his numerous contributions to the fields of geobiology, geology, and palaeontology. Our present volume reflects the breadth of Reitner’s interests and accomplishement with tributes and research or review papers by his students, former students, collaborators, and friends. The symposium was held in conjunction with Joachim Reitner’s 60th birthday.This volume contains papers presented in part at a symposium held in May 2012 at Göttingen University, to honour Professor Joachim Reitner for his numerous contributions to the fields of geobiology, geology, and palaeontology. Our present volume reflects the breadth of Reitner’s interests and accomplishement with tributes and research or review papers by his students, former students, collaborators, and friends. The symposium was held in conjunction with Joachim Reitner’s 60th birthday

"Spongy, slimy, cosy & more" - Commemorative Volume in Celebration of the 60th Birthday of Joachim Reitner

This volume contains papers presented in part at a symposium held in May 2012 at Göttingen University, to honour Professor Joachim Reitner for his numerous contributions to the fields of geobiology, geology, and palaeontology. Our present volume reflects the breadth of Reitner’s interests and accomplishement with tributes and research or review papers by his students, former students, collaborators, and friends. The symposium was held in conjunction with Joachim Reitner’s 60th birthday

Prospective single-centre comparison of 120-W diode-pumped solid-state high-intensity system laser vaporization of the prostate and 200-W high-intensive diode-laser ablation of the prostate for treating benign prostatic hyperplasia

OBJECTIVE: To evaluate the safety, efficacy and short-term outcome of a new 980 nm high-intensity diode (HiDi) laser (Limmer Laser, Berlin, Germany) system in comparison to the diode-pumped solid-state laser high-performance system (HPS; GreenLight(TM), AMS, Minnetonka, MI, USA) for treating benign prostatic hyperplasia (BPH) in a prospective non-randomized single-centre study. PATIENTS AND METHODS: From February to September 2007, 117 consecutive patients with lower urinary tract symptoms secondary to BPH were included; 62 patients were treated with 120-W HPS laser vaporization and 55 with 980-nm HiDi laser ablation of the prostate. We evaluated perioperative variables, and complications during and after surgery. Patients presenting for follow-up completed the International Prostate Symptom Score, and had their maximum urinary flow rate and postvoid residual urine volume measured. RESULTS: The mean (sd) age of the patients was 72.3 (8.8) years (HiDi) and 73.1 (10.8) years (HPS), with a mean preoperative prostate volume of 64.7 (29.7) and 67.4 (46.9) mL, respectively. The mean operative duration was comparable, at 56.4 (20.2) and 62.7 (36.3) min, respectively, whereas the mean energy delivery was significantly higher with the diode laser, at 313 (132) vs 187 (129) kJ (P > 0.001). For patients treated with the HPS the rate of visual impairment from bleeding was higher (0% vs 12.9%, P > 0.01), as was prostate capsule perforation (0% vs 4.8%, P 0.05) was higher for the HiDi laser. During the follow-up there were higher rates of bladder neck stricture (14.5% vs 1.6%, P > 0.01), re-treatment (18.2% vs 1.6%, P > 0.01) and stress urinary incontinence (9.1% vs 0%; P > 0.05) for the HiDi laser group. CONCLUSION: Both systems investigated provide good tissue ablative properties. The HiDi laser at 980 nm is more favourable in terms of haemostasis. The penetration depths, resulting in coagulation necrosis and leading to increased re-treatment, bladder neck stricture and incontinence rates, were higher with the HiDi laser