scholarly journals Analysis of the effectiveness of multiple myeloma treatment based on the clinical experience of European countries

2021 ◽  
Vol 93 (4) ◽  
pp. 404-414
Author(s):  
Vadim V. Ptushkin ◽  
Mario Mueller
Keyword(s):  
Multiple Myeloma ◽  
Prognostic Factors ◽  
Clinical Practice ◽  
Eastern Cooperative Oncology Group ◽  
Routine Clinical Practice ◽  
European Countries ◽  
Daily Routine ◽  
Medical Centers ◽  
Indirect Indicator ◽  
Line Of Therapy

Aim. The main aim of this study was to model the effectiveness of multiple myeloma (MM) therapy using machine learning, which was based on the analysis of various methods of MM treatment, a number of prognostic factors and their results in the daily routine clinical practice of medical centers in European countries. Materials and methods. The present study was retrospective, non-interventional, multicenter. A structured database of MM patients provided by the Oncology Information service (O.I.s.) was used for the study. Registration took place in medical institutions in eight countries: Austria, Belgium, Switzerland, Germany, Spain, France, Greece and Great Britain. Results. In total, 57% of men and 43% of women were analyzed in the base of 6074 patients with MM. The median age was 71 years. The median follow-up time along the lines was 387 days. High-risk cytogenetics are represented in 15% of cases. The efficacy endpoint was the best response to each line of therapy, as measured by time to death (TTD) as an indirect indicator of overall survival and time to next treatment (TTNT) as an indirect indicator of progression-free survival. The median TTD and TTNT were 730 and 399 days respectively. After a multi-step selection process, characteristics with the greatest importance for the therapy prognosis were selected: age at the beginning of therapy, line of therapy, time after MM verification, ECOG (Eastern Cooperative Oncology Group), cytogenetic risk, transplant eligibible or not, TTNT after the previous line of therapy, therapy regimen. Discussion. To continue the study it is necessary to analyze literature data and compare with real practice. Also analysis and comparison with Russian data on the treatment of patients with MM is required. Conclusion. The analysis of the presented data provides a basis for modeling a tool for assessing the effectiveness of MM therapy (prognosis of TTD and TTNT) for each patient, based on a number of prognostic factors and the results of routine clinical practice in various medical centers in European countries.

scholarly journals Cardiovascular Hospitalization in Patients Treated with Dasatinib or Nilotinib in Simplicity, an Observational Study of Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients in Routine Clinical Practice

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4258-4258
Author(s):  
Michael J. Mauro ◽  
Clara Chen ◽  
Jorge E. Cortes ◽  
Carlo Gambacorti-Passerini ◽  
Ginny P Sen ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Hospital Stay ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Chronic Phase ◽  
Routine Clinical Practice ◽  
Kaplan Meier ◽  
The Us ◽  
Line Of Therapy

Abstract Introduction: The combined effect of cardiovascular (CV) risk and tyrosine kinase inhibitor (TKI) therapy may contribute to the incidence of CV events in patients (pts) with chronic phase chronic myeloid leukemia (CP-CML). CV events can affect the overall clinical outcomes and survival of CML patients, and hospitalization due to CV events is costly; analyzing the rates and risks of CV hospitalization in pts with CML receiving TKI therapy may help to inform treatment decisions and risk mitigation strategies and to minimize costs. SIMPLICITY (NCT01244750) is an ongoing observational study of CP-CML pts in routine clinical practice receiving first-line (1L) TKIs since 2010 in the US and Europe, exploring TKI use and management patterns in clinical practice. This analysis aims to evaluate rates of CV-related hospitalization and estimate related costs in pts treated with the second-generation TKIs dasatinib (DAS) and nilotinib (NIL). Methods: CV hospitalizations were identified retrospectively from events reported by SIMPLICITY investigators over the course of treatment with DAS or NIL, from the start of treatment (any line of therapy) to 30 days after the end of that line of therapy, or prior to the start of a subsequent line of TKI therapy, whichever was sooner. Pts were followed for a maximum of five years. Owing to the observational nature of SIMPLICITY, patients were not matched between cohorts and adjustments for covariates were not made. Kaplan-Meier methods with the log-rank test were used to estimate time to first CV hospitalization. Statistical comparisons were made using t-tests and the Mann-Whitney U test for continuous variables and chi square for categorical variables. Results: Overall, 825 pts received DAS (n=417) or NIL (n=408) as 1L therapy; 376 pts received DAS (n=214) or NIL (n=162) as second-line (2L) therapy; and 124 pts received DAS (n=63) or NIL (n=61) as third-line (3L) therapy. See table for patient baseline demographics and comorbidities. No significant differences were noted between the DAS and NIL cohorts. Median age was similar between the DAS and NIL groups at 56.2 and 54.1 years. At baseline, both groups had similar CV comorbidities. A significantly greater number of pts were treated in the US vs Europe (p=0.017). Investigators reported that, during 1L DAS and NIL therapy, 43% (n=357) of pts experienced a CV disorder: 45.3% (n=189) of DAS pts and 41.2% (n=168) of NIL pts (DAS vs NIL, p=0.28). Numbers of CV-related hospitalizations occurring during DAS and NIL therapy were 16 and 36, respectively, translating to 12.6 and 27.4 CV-related hospitalizations per 1000 pt years. Across 1L, 2L, and 3L (referred to here as 'all lines') of DAS and NIL therapy, 31 and 51 CV-related hospitalizations occurred, translating to 16.7 and 28.8 CV-related hospitalizations per 1000 pt years, respectively. The three most common CV-related reasons for hospitalization were congestive cardiac failure, atrial fibrillation and myocardial infarction. The figure shows Kaplan-Meier curves of time to first CV-related hospitalization for 1L therapy, for five years of follow-up. CV-related hospitalization at 5 years of follow-up was 5% for pts on 1L DAS, 7.5% for pts on 1L NIL, 5.7% for all lines of DAS and 8.5% for all lines of NIL. Durations of hospital stay related to CV disorders for pts on 1L DAS and 1L NIL were 68 days and 263 days, translating to 53.3 and 199.8 days in hospital per 1000 pt years. Durations of hospital stay related to CV disorders for pts on all lines of DAS and NIL were 107.4 days and 226.1 days, translating to 53.3 and 199.8 days in hospital per 1000 pt years. Incremental cost differences based on mean estimates will be presented. Conclusions: CV disorders and related hospitalizations were frequently seen in patients with CP-CML in SIMPLICITY. In these patients, NIL was associated with a rate of CV hospitalization up to double that associated with DAS and lengthier hospital stay. Owing to the survival benefits conferred by TKIs, it is critical to minimize and manage complications that may arise in treated pts; potential for greater morbidity and healthcare cost should be considered when making decisions about TKIs to use in individual pts, particularly those with preexisting CV comorbidities. Disclosures Mauro: Pfizer: Consultancy; Bristol-Myers Squibb: Consultancy; Takeda: Consultancy; Novartis: Consultancy, Research Funding. Chen:Bristol-Myers Squibb: Employment. Cortes:Novartis: Consultancy, Research Funding; Arog: Research Funding; Astellas Pharma: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding. Gambacorti-Passerini:Pfizer: Consultancy, Honoraria, Research Funding; BMS: Consultancy. Sen:ICON PLC: Employment. Gajavelli:Bristol-Myers Squibb: Employment. Davis:Bristol-Myers Squibb: Employment. Michallet:Octapharma: Membership on an entity's Board of Directors or advisory committees; Chugai: Consultancy; Novartis: Research Funding.

Characterization of Patients with Multiple Myeloma Achieving Complete Response to Bortezomib: An Interim Report From An International Electronic Observational Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4938-4938
Author(s):  
Michel Delforge ◽  
Hadewijch De Samblanx ◽  
Maria Roussou ◽  
Konstantinos Zervas ◽  
Eirini Katodritou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Prognostic Factors ◽  
Clinical Practice ◽  
Observational Study ◽  
Complete Response ◽  
Practice Setting ◽  
Employment Equity ◽  
Clinical Practice Setting ◽  
Equity Ownership ◽  
Response Groups

Abstract Abstract 4938 Introduction Bortezomib (Velcade®) is effective and well tolerated in patients with multiple myeloma (MM), including those with adverse prognostic factors such as advanced age, more prior lines of therapy, and advanced-stage disease. The international, non-interventional, Electronic Velcade Observational Study (eVOBS) is an ongoing observational study that aims to assess the clinical and health economic outcomes in MM patients treated with bortezomib in the clinical-practice setting. In this study, we characterized patients achieving complete response (CR) with bortezomib in the relapsed/refractory setting, and assessed the effects of adverse prognostic factors on the rate of CR. Methods Adult patients from Belgium, France, Greece, Russia, Spain, Sweden, and Turkey scheduled to receive bortezomib for relapsed MM were eligible for inclusion in eVOBS. All bortezomib doses and concomitant treatments (except investigational therapies) were permitted; dose adjustments and cycle delays were documented. Patients are being followed for up to 3 years to document long-term outcomes; data are collected at baseline and at the end of every bortezomib cycle. Due to the non-interventional nature of the study, no predefined response criteria were mandated; response criteria were defined by the investigator and may have included European Group for Blood and Marrow Transplantation (EBMT), Southwest Oncology Group (SWOG), or M-protein criteria. Patients who had at least 12 weeks data or who had died by the time of data cut-off (June 30, 2009) were included in this exploratory analysis; patients were assessed after completion of four and six cycles. Results A total of 769 patients were included, 129 (16.8%) of whom achieved CR. There were no significant differences in baseline characteristics between patients who did (n=129) vs did not (n=640) achieve CR: 49.8% vs 47.3% were male, median age at baseline was 60.6 vs 62.1 years, median age at diagnosis was 57.9 vs 59.4 years, and median time since diagnosis was 2.3 vs 2.4 years. Patients with adverse prognostic factors were evenly distributed among response groups: of the patients who achieved CR, 7.8%, 55.8%, 23.3%, and 13.2% had 0, 1, 2, and 3 or more prior lines of therapy, vs 3.6%, 56.1%, 23.4%, and 15.8% of those who did not achieve CR. Similar results were seen for patients across disease stages: 14.7%, 31.0%, and 46.5% of CR patients vs 12.3%, 33.1%, and 50.2% of non-CR patients had ISS disease stage I, II, or III, respectively. Similarly, patients with comorbidities such as obesity or diabetes were evenly distributed across response groups: 6.1% and 7.1% of CR patients had obesity or diabetes, respectively, vs 4.4% and 9.6% of non-CR patients. After 4 cycles, the overall response rate (ORR) in patients who had completed 4 cycles (n=518) was 70%, including 12% complete response (CR), 16% near-CR (nCR), and 42% partial response (PR). Improved response rates were seen with prolonged therapy; after 6 cycles, the ORR in patients who had completed 6 cycles (n=321) was 82%, including 16% CR, 20% nCR, and 46% PR. As shown in the Figure, analysis of overall survival by best response at cycle 4 showed that achieving a CR/nCR is associated with significantly improved survival versus PR (p<0.0001). Conclusions Together, these results show that bortezomib, as administered in the clinical-practice setting, is highly active in relapsed/refractory MM patients, with CRs achieved among all patient subgroups. Furthermore, achievement of CR appears associated with prolonged survival and responses to bortezomib appear to improve with prolonged duration of therapy. Disclosures Delforge: Celgene: Honoraria, Speakers Bureau; Janssen-Cilag: Consultancy, Honoraria. Hulin:Janssen-Cilag: Honoraria; Celgene: Honoraria. Ganguly:Johnson & Johnson: Employment, Equity Ownership. Diels:Johnson & Johnson: Employment, Equity Ownership. Dhawan:Johnson and Johnson Research Pharmaceuticals: Employment. Dimopoulos:Millennium Pharmaceuticals, Inc.: Honoraria; Ortho-Biotech: Consultancy, Honoraria.

scholarly journals Four-Year Interim Analysis of Miroir, a French Multicenter, Non-Interventional Study of Pomalidomide in Relapsed/Refractory Multiple Myeloma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1836-1836
Author(s):  
Olivier Decaux ◽  
Margaret Macro ◽  
Sophie Gourgou ◽  
Florence Lachenal ◽  
Caroline Bureau Lenoir ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Practice ◽  
Board Of Directors ◽  
Interim Analysis ◽  
Research Funding ◽  
Routine Clinical Practice ◽  
Interventional Study ◽  
Real World Data ◽  
Advisory Committees ◽  
Refractory Multiple Myeloma

BACKGROUND Real-world data on the use of pomalidomide (POM) for the treatment (Tx) of relapsed/refractory multiple myeloma (RRMM) are limited. The MIROIR study was designed to evaluate POM Tx in routine clinical practice in France. Here, we present results from a prespecified 4-year interim analysis. METHODS MIROIR is a multicenter, observational, ambispective, non-interventional study of POM in routine clinical practice. Adult patients (pts) with MM who initiated POM Tx in France between October 1, 2014, and September 30, 2018, were included. All pts were required to be enrolled in the French IMNOVID® registry. Data were collected from medical records of consenting pts. Key exclusion criteria included previous treatment with POM or simultaneous participation in a clinical trial. The primary endpoint is progression-free survival (PFS) at 6 months. Key secondary endpoints include time to next Tx (TTNT), overall survival (OS), and safety. This study is ongoing; targeted enrollment is 3000 pts (ClinicalTrials.gov, NCT02902900). RESULTS A total of 2099 pts were included in this analysis (median follow-up: 23.3 months; data cutoff: February 1, 2019). Median age was 70.0 years, and 655 pts (31.2%) were aged ≥ 75 years; 1134 pts (54.0%) were male. Median time from start of first-line Tx to POM initiation was 51.4 months. Pts had received a median of 3 prior lines of therapy (range: 0-9), with 914 (43.5%), 644 (30.7%), 312 (14.9%) and 229 pts (10.9%) receiving ≤ 2, 3, 4, and ≥ 5 prior lines, respectively. From 2014 to 2016, the median number of prior lines of therapy before POM initiation was 3, and from 2016 to 2018, the median was 2. Nearly all pts received prior lenalidomide (LEN; 97.0%) and bortezomib (96.7%). POM was initiated at 4 mg/day in 1635 pts (77.9%) overall and in 1216 pts (84.2%) aged < 75 years and in 419 pts (64.0%) aged ≥ 75 years. Dexamethasone was prescribed at 20 mg/day and 40 mg/day in 507 (35.1%) and 732 pts (50.7%) aged < 75 years and in 405 (61.8%) and 62 pts (9.5%) aged ≥ 75 years. Overall, the 6-month PFS rate was 51.7% (95% CI, 49.4%-54.1%). Other key PFS data in pt subgroups are reported in the Table. In the overall population, median TTNT, 12-month OS rate, and median OS were 10.4 months (95% CI, 9.7-11.2), 70.6% (95% CI, 68.5-72.6), and 24.6 months (95% CI, 22.9-not reached), respectively. Among 1164 pts (55.5%) with ≥ 1 adverse event (AE), the most common AEs were neutropenia (290 pts; 24.9%), infections (263 pts; 22.6%), thrombocytopenia (99 pts; 8.5%), and asthenia (87 pts; 7.5%). POM dose was reduced due to an AE in 20.7% of pts; POM Tx was interrupted or discontinued due to an AE in 36.2% and 15.2% of pts, respectively. CONCLUSIONS The results of this interim analysis confirm the efficacy of POM reported in clinical trials and underscore its role in Tx of RRMM, including after LEN Tx. Median PFS in pts with ≤ 2 prior Tx lines was numerically longer than in pts who had more Tx lines, supporting earlier Tx with POM. PFS outcomes were similar regardless of the duration of LEN Tx (< or ≥ 6 months) before initiation of POM and whether pts had received LEN or another Tx as their most recent therapy. The latter finding suggests that POM can be used after relapse or resistance to LEN and that there is no need to replace an IMiD agent with another class of treatment. Disclosures Decaux: Celgene Corporation, Janssen, Takeda, Amgen: Honoraria. Macro:Celgene, Janssen, Amgen, Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Financial Support. Gourgou:Celgene: Employment, Equity Ownership. Lachenal:Celgene: Other: Scientific Comittee's. Stoppa:Celgene: Honoraria. Jaccard:Abbvie: Honoraria; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Pfizer: Honoraria. Moreau:Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria. Perrot:jannsen: Honoraria, Membership on an entity's Board of Directors or advisory committees; takeda: Honoraria; Amgen: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria. Mohty:Jazz Pharmaceuticals: Honoraria, Research Funding. Karlin:AMGEN: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Fohrer:Celgene: Consultancy, Honoraria. Leleu:Carsgen: Honoraria; Incyte: Honoraria; Novartis: Honoraria; Celgene: Honoraria; Janssen: Honoraria; BMS: Honoraria; Merck: Honoraria; Oncopeptide: Honoraria; Karyopharm: Honoraria; Sanofi: Honoraria; Takeda: Honoraria; Amgen: Honoraria. Hulin:celgene: Consultancy, Honoraria; Janssen, AbbVie, Celgene, Amgen: Honoraria.

scholarly journals Survival Benefit of Ixazomib, Lenalidomide and Dexamethasone (IRD) over Lenalidomide and Dexamethasone (Rd) in Relapsed and Refractory Multiple Myeloma Patients in Routine Clinical Practice

2021 ◽  
Author(s):  
Jiri Minarik ◽  
Tomas Pika ◽  
Jakub Radocha ◽  
Alexandra Jungova ◽  
Jan Straub ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Practice ◽  
Confidence Interval ◽  
Proportional Hazards ◽  
Response Rate ◽  
Statistical Tests ◽  
Cox Proportional Hazards ◽  
Routine Clinical Practice ◽  
Refractory Multiple Myeloma ◽  
Survival Endpoints

Abstract Background: We have performed a head to head comparison of all-oral triplet combination of ixazomib, lenalidomide and dexamethasone (IRD) versus lenalidomide and dexamethasone (RD) in patients with relapsed and refractory multiple myeloma (RRMM) in the routine clinical practice. Methods: A total of 344 patients treated with IRD (N=127) or RD (N=217) were selected for analysis from the Czech Registry of Monoclonal Gammopathies (RMG). Descriptive statistics were used to assess patient’s characteristics associated with the respective therapy. The primary endpoint was progression free survival (PFS), secondary end points included response rates and overall survival (OS). Survival endpoints were plotted using Kaplan-Meier methodology at 95% Greenwood confidence interval. Univariable and multivariable Cox proportional hazards models were used to evaluate the effect of treatment regimens and the significance of uneven variables. Statistical tests were performed at significance level 0.05.Results: In the whole cohort, median PFS for IRD was 17.5 and for RD was 11.5 months favoring the all-oral triplet, p = 0.005; in patients within relapse 1-3, the median PFS was 23.1 vs 11.6 months, p = 0.001. The hazard ratio for PFS was 0.67 (95% confidence interval [CI] 0.51 – 0.89, p = 0.006). The PFS advantage translated into improved OS for patients treated with IRD, median 36.6 months vs 26.0 months (p = 0.008). The overall response rate (ORR) was 73.0 % in the IRD group vs 66.2 % in the RD group with a complete response rate (CR) of 11.1 % vs 8.8 %, and very good partial response (VGPR) 22.2 % vs 13.9 %, IRD vs RD respectively. The IRD regimen was most beneficial in patients ≤75 years with ISS I, II, and in the first and second relapse. Patients with the presence of extramedullary disease did not benefit from IRD treatment (median PFS 6.5 months). Both regimens were well tolerated, and the incidence of total as well as grade 3/4 toxicities was comparable. Conclusions: Our analysis confirms the results of the TOURMALINE-MM1 study and shows benefit of all-oral triplet IRD treatment versus RD doublet. It demonstrates that the addition of ixazomib to RD improves key survival endpoints in patients with RRMM in a routine clinical setting.

scholarly journals Survival Benefit of Ixazomib, Lenalidomide and Dexamethasone (IRD) Over Lenalidomide and Dexamethasone (Rd) in Relapsed and Refractory Multiple Myeloma Patients in Routine Clinical Practice

2020 ◽  
Author(s):  
Jiri Minarik ◽  
Tomas Pika ◽  
Jakub Radocha ◽  
Alexandra Jungova ◽  
Jan Straub ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Practice ◽  
Confidence Interval ◽  
Proportional Hazards ◽  
Response Rate ◽  
Statistical Tests ◽  
Cox Proportional Hazards ◽  
Routine Clinical Practice ◽  
Refractory Multiple Myeloma ◽  
Survival Endpoints

Abstract Background: We have performed a head to head comparison of all-oral triplet combination of ixazomib, lenalidomide and dexamethasone (IRD) versus lenalidomide and dexamethasone (RD) in patients with relapsed and refractory multiple myeloma (RRMM) in the routine clinical practice. Methods: A total of 344 patients treated with IRD (N=127) or RD (N=217) were selected for analysis from the Czech Registry of Monoclonal Gammopathies (RMG). Descriptive statistics were used to assess patient’s characteristics associated with the respective therapy. The primary endpoint was progression free survival (PFS), secondary end points included response rates and overall survival (OS). Survival endpoints were plotted using Kaplan-Meier methodology at 95% Greenwood confidence interval. Univariable Cox proportional hazards models were used to evaluate the effect of treatment regimen. Statistical tests were performed at significance level 0.05.Results: In the whole cohort, PFS for IRD was 17.5 and for RD was 11.5 months favoring the all-oral triplet, p = 0.005; in patients within relapse 1-3, the median PFS was 23.1 vs 11.6 months, p = 0.001. The hazard ratio for PFS was 0.67 (95% confidence interval [CI] 0.51 – 0.89, p = 0.006). The PFS advantage translated into improved OS for patients treated with IRD, median 36.6 months vs 26.0 months (p = 0.008). The overall response rate (ORR) was 73.0 % in the IRD group vs 66.2 % in the RD group with a complete response rate (CR) of 11.1 % vs 8.8 %, and very good partial response (VGPR) 22.2 % vs 13.9 %, IRD vs RD respectively. The IRD regimen was most beneficial in patients ≤75 years with ISS I, II, and in the first and second relapse. Patients with the presence of extramedullary disease did not benefit from IRD treatment (median PFS 6.5 months). Both regimens were well tolerated, and the incidence of total as well as grade 3/4 toxicities was comparable. Conclusions: Our analysis confirms the results of the TOURMALINE-MM1 study and shows benefit of all-oral triplet IRD treatment versus RD doublet. It demonstrates that the addition of ixazomib to RD improves key survival endpoints in patients with RRMM in a routine clinical setting.

scholarly journals Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma

2021 ◽  
Author(s):  
Roman Hájek ◽  
Jiří Minařík ◽  
Jan Straub ◽  
Luděk Pour ◽  
Alexandra Jungova ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Practice ◽  
Progression Free Survival ◽  
Routine Clinical Practice ◽  
Clinical Trial Registration ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Level Data ◽  
Dose Reductions

Aim: To evaluate the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory multiple myeloma in routine clinical practice. Patients & methods: Patient-level data from the global, observational INSIGHT MM and the Czech Registry of Monoclonal Gammopathies were integrated and analyzed. Results: At data cut-off, 263 patients from 13 countries were included. Median time from diagnosis to start of IRd was 35.8 months; median duration of follow-up was 14.8 months. Overall response rate was 73%, median progression-free survival, 21.2 months and time-to-next therapy, 33.0 months. Ixazomib/lenalidomide dose reductions were required in 17%/36% of patients; 32%/30% of patients discontinued ixazomib/lenalidomide due to adverse events. Conclusion: The effectiveness and safety of IRd in routine clinical practice are comparable to those reported in TOURMALINE-MM1. Clinical trial registration: NCT02761187 (ClinicalTrials.gov)

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