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1.
JCO Oncol Pract ; 19(9): 793-798, 2023 09.
Article in English | MEDLINE | ID: mdl-37418682

ABSTRACT

PURPOSE: The incidence of multiple myeloma (MM) is two to three times higher in Black patients compared with other races, making it the most common hematologic malignancy in this patient population. Current treatment guidelines recommend the combination of a proteasome inhibitor, an immunomodulatory agent, and a corticosteroid as preferred induction therapy. Bortezomib use comes with the risk of peripheral neuropathy (PN) and potential need for dose reduction, therapy interruption, and additional supportive medications. Known risk factors for bortezomib-induced peripheral neuropathy (BIPN) include diabetes mellitus, previous thalidomide, advanced age, and obesity. We aimed to determine the potential association between Black race and incidence of BIPN. PATIENTS AND METHODS: We identified a cohort of 748 patients with newly diagnosed MM who received induction with bortezomib, lenalidomide, and dexamethasone from 2007 to 2016. One hundred forty Black patients were matched with 140 non-Black patients on age, sex, BMI, and route of bortezomib administration. Incidence of BIPN was a binary event defined as new use of a neuropathy medication, bortezomib dose reduction, dose omission, or discontinuation because of PN. RESULTS: The incidence of BIPN was higher in Black patients (46%) compared with non-Black patients (34%; P = .05) in both univariate (odds ratio [OR], 1.61; 95% CI, 1.00 to 2.61; P = .052) and multivariable analyses (OR, 1.64; 95% CI, 1.01 to 2.67; P = .047). No significant differences in BIPN were seen when stratified by route of administration. CONCLUSION: These data indicate that Black race is an independent risk factor for the development of BIPN. Additional prevention strategies, close monitoring, and appropriate supportive care measures are warranted for these patients.


Subject(s)
Multiple Myeloma , Peripheral Nervous System Diseases , Humans , Bortezomib/adverse effects , Lenalidomide/adverse effects , Multiple Myeloma/complications , Multiple Myeloma/drug therapy , Multiple Myeloma/ethnology , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/ethnology , Thalidomide/adverse effects , Black or African American
2.
J Cancer Policy ; 37: 100433, 2023 09.
Article in English | MEDLINE | ID: mdl-37468042

ABSTRACT

INTRODUCTION: Multiple myeloma (MM) is more common in Black persons when compared to non-Hispanic White persons. The International Myeloma Working Group (IMWG) provides consensus for diagnosis and treatment of MM. Our study aimed to assess the racial composition of supporting studies used by IMWG to publish their guidelines METHODS: We performed a cross sectional study that included all IMWG publications up to July 2022. References cited in each publication were reviewed. Review articles, comments, editorials, case reports, and animal-based studies were excluded. RESULTS: A total of 59 IMWG publications with 3956 references were reviewed. Final analysis included 2047 references of which 39 % (n = 804) were clinical trials, 35 % (n = 712) were observational studies, 20 % (n = 401) were diagnostic and or genetic testing-based studies, 3 % (n = 65) were population-based analysis and 3 % (n = 65) classified as others. Only 10.4 % of included references (n = 213/2047) reported race/ethnicity of studied patients. The total number of patients in all referenced studies were 5,747,920, only 2.6 % (n = 150,790) black patients. Of the trials referenced and done exclusively in the US, 41 out of 282 (14.5 %) reported race/ethnicity with a total number of patients of 38,050 of which 2493 (6.5 %) were black patients. CONCLUSION: IMWG guidelines were based mainly on studies that did not include enough Black patients. Guidelines should consider inclusion of observational, diagnostic and population-based studies with more black patients to allow for better reflection of disease prevalence, clinical characteristics and/or outcomes.


Subject(s)
Black People , Clinical Studies as Topic , Multiple Myeloma , Practice Guidelines as Topic , Humans , Cross-Sectional Studies , Ethnicity , Multiple Myeloma/diagnosis , Multiple Myeloma/epidemiology , Multiple Myeloma/ethnology , Multiple Myeloma/therapy , White , Clinical Studies as Topic/standards , Patient Selection , Practice Guidelines as Topic/standards
3.
Blood Cancer J ; 13(1): 109, 2023 07 18.
Article in English | MEDLINE | ID: mdl-37460466

ABSTRACT

There are disparities in outcomes for patients with multiple myeloma (MM). We evaluated the influence of sociodemographic factors on global disparities in outcomes for patients with MM. This rapid evidence assessment (PROSPERO, CRD42021248461) followed PRISMA-P guidelines and used the PICOS framework. PubMed and Embase® were searched for articles in English from 2011 to 2021. The title, abstract, and full text of articles were screened according to inclusion/exclusion criteria. The sociodemographic factors assessed were age, sex, race/ethnicity, socioeconomic status, and geographic location. Outcomes were diagnosis, access to treatment, and patient outcomes. Of 84 articles included, 48 were US-based. Worldwide, increasing age and low socioeconomic status were associated with worse patient outcomes. In the US, men typically had worse outcomes than women, although women had poorer access to treatment, as did Black, Asian, and Hispanic patients. No consistent disparities due to sex were seen outside the US, and for most factors and outcomes, no consistent disparities could be identified globally. Too few studies examined disparities in diagnosis to draw firm conclusions. This first systematic analysis of health disparities in patients with MM identified specific populations affected, highlighting a need for additional research focused on assessing patterns, trends, and underlying drivers of disparities in MM.


Subject(s)
Health Status Disparities , Multiple Myeloma , Female , Humans , Male , Ethnicity/statistics & numerical data , Hispanic or Latino/statistics & numerical data , Meta-Analysis as Topic , Multiple Myeloma/diagnosis , Multiple Myeloma/epidemiology , Multiple Myeloma/ethnology , Multiple Myeloma/therapy , Systematic Reviews as Topic , Healthcare Disparities/statistics & numerical data , Sex Factors , Black or African American/statistics & numerical data , Asian/statistics & numerical data
4.
Blood ; 142(3): 235-243, 2023 07 20.
Article in English | MEDLINE | ID: mdl-37140031

ABSTRACT

The narrow eligibility criteria may contribute to the underrepresentation of racial and ethnic subgroups in cancer clinical trials. We conducted a retrospective pooled analysis of multicenter global clinical trials submitted to the US Food and Drug Administration between 2006 and 2019 to support the approval of the use of multiple myeloma (MM) therapies that analyze the rates and reasons for trial ineligibility based on race and ethnicity in MM clinical trials. Race and ethnicity were coded per Office of Management and Budget standards. Patients flagged as having screen failures were identified as ineligible. Ineligibility rates were calculated as the percentage of patients who were ineligible compared with the screened population within the respective racial and ethnic subgroups. Trial eligibility criteria were grouped into specific categories to analyze the reasons for trial ineligibility. Black patients (24%) and other (23%) race subgroups had higher ineligibility rates than White patients (17%). The Asian race had the lowest ineligibility rate (12%) among all racial subgroups. Failure to meet the hematologic laboratory criteria (19%) and treatment-related criteria (17%) were the most common reasons for ineligibility among Black patients and were more common in Black patients than in other races. Failure to meet disease-related criteria was the most common reason for ineligibility among White (28%) and Asian (29%) participants. Our analysis indicates that specific eligibility criteria may contribute to enrollment disparities for racial and ethnic subgroups in MM clinical trials. However, the small number of screened patients in the underrepresented racial and ethnic subgroups limits definitive conclusions.


Subject(s)
Multiple Myeloma , Humans , Black People , Ethnicity/statistics & numerical data , Multiple Myeloma/epidemiology , Multiple Myeloma/ethnology , Multiple Myeloma/therapy , Retrospective Studies , Clinical Trials as Topic/statistics & numerical data , Population Groups/ethnology , Population Groups/statistics & numerical data , Racial Groups , Internationality , Patient Selection , White People , Asian People
5.
JAMA Netw Open ; 5(4): e228161, 2022 04 01.
Article in English | MEDLINE | ID: mdl-35442451

ABSTRACT

Importance: Disparities that affect Black persons with various hematological malignant neoplasms are substantial, yet little is known about disparities related to the use of US Food and Drug Administration (FDA)-approved chimeric antigen receptor-T cell (CAR-T) therapy. Objective: To examine the enrollment of Black participants in clinical trials that resulted in a subsequent FDA approval of CAR-T products in hematological malignant neoplasms. Design, Setting, and Participants: A cross-sectional study was performed using publicly available data on drug products and demographic subgroups from Drugs@fda in the period of August 2017 to May 2021. Data analysis included patients with large B cell lymphoma, follicular lymphoma, mantle cell lymphoma, acute lymphoblastic leukemia, and multiple myeloma who were enrolled into 7 clinical trials that investigated various CAR-T products. The study was conducted from July 1, 2021, to November 30, 2021. Main Outcomes and Measures: Frequencies of participation of Black participants were calculated with adjustment for disease prevalence. Results: Of the 1057 enrolled patients included in the study, CAR-T products were given to 746 patients (71%), and efficacy was reported for 729 enrolled patients (69%) across all the approved CAR-T products and indications. Most patients (1015 patients [96%]) were enrolled in the US. Black participants were included in the racial category other in the study that supported tisagenlecleucel approval in acute lymphoblastic leukemia; otherwise, their enrollment was specified either in the study publication and/or the demographic subgroup information available under the FDA product labeling information. The number of Black participants who received the CAR-T product and had reported efficacy varied between studies (range, 1-12 participants [2%-5%]). Adjusted prevalence measures showed the lowest participation to prevalence ratio of 0.2 for multiple myeloma and 0.6 for large B cell lymphoma. Conclusions and Relevance: The findings of this study suggest that there are substantial disparities affecting Black patients across all approved CAR-T products used to treat hematological malignant neoplasms with otherwise limited effective treatment options. The study findings might aid policy discussions regarding the immediate need of regulations that enforce certain thresholds of Black patients' enrollment before granting FDA approval.


Subject(s)
Black or African American , Cell- and Tissue-Based Therapy , Clinical Trials as Topic , Drug Approval , Hematologic Neoplasms , Patient Participation , Adult , Cross-Sectional Studies , Health Status Disparities , Hematologic Neoplasms/drug therapy , Hematologic Neoplasms/ethnology , Humans , Lymphoma, Large B-Cell, Diffuse/drug therapy , Lymphoma, Large B-Cell, Diffuse/ethnology , Multiple Myeloma/drug therapy , Multiple Myeloma/ethnology , Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy , Precursor Cell Lymphoblastic Leukemia-Lymphoma/ethnology , Receptors, Chimeric Antigen/therapeutic use , United States , United States Food and Drug Administration
6.
Sci Rep ; 11(1): 22907, 2021 11 25.
Article in English | MEDLINE | ID: mdl-34824362

ABSTRACT

The number of elderly people is rapidly growing, and the proportion of elderly patients with multiple myeloma (MM) continues to increase. This study aimed to develop a frailty assessment tool based on clinical data and to estimate its feasibility in elderly patients with MM. This study analyzed data from 728 elderly transplant-ineligible patients with newly diagnosed MM who were treated between January 2010 and October 2019. Our clinical frailty index included age (< 75, and ≥ 75 years), Charlson comorbidity index (CCI; < 3 and ≥ 3), and Eastern Cooperative Oncology Group performance status score (ECOG score; 0, 1-2, and ≥ 3). Patients were classified as fit, intermediate, or frail if they had a score of 0, 1, or ≥ 2, respectively. The overall survival rates differed significantly according to frailty (fit vs. intermediate: hazard ratio [HR] = 2.41; 95% confidence interval [CI] = 1.43-4.06; P = 0.001; fit vs. frail: HR = 4.61; 95% CI = 2.74-7.77; P < 0.001 and intermediate vs. frail: HR = 1.91, 95% CI = 1.49-2.45, P < 0.001, respectively). The frail had significantly shorter EFS compared with the fit and intermediate group in our frailty index (fit vs. intermediate: HR = 1.34, 95% CI = 0.92-1.96, P = 0.132; fit vs. frail: HR = 2.06, 95% CI = 1.40-3.02, P < 0.001; and intermediate vs. frail: HR = 1.53, 95% CI = 1.22-1.92, P < 0.001, respectively). The new clinical frailty index, which is based on age, CCI, and ECOG PS, can easily assess frailty in elderly patients with MM and can be helpful in predicting survival outcomes in real world clinical setting.


Subject(s)
Decision Support Techniques , Frail Elderly , Frailty/diagnosis , Geriatric Assessment , Multiple Myeloma/diagnosis , Age Factors , Aged , Aged, 80 and over , Asian People , Feasibility Studies , Female , Frailty/ethnology , Frailty/mortality , Humans , Male , Middle Aged , Multiple Myeloma/drug therapy , Multiple Myeloma/ethnology , Multiple Myeloma/mortality , Predictive Value of Tests , Progression-Free Survival , Republic of Korea , Risk Assessment , Risk Factors
8.
Cancer Epidemiol ; 73: 101974, 2021 08.
Article in English | MEDLINE | ID: mdl-34243048

ABSTRACT

PURPOSE: Multiple Myeloma (MM), the second leading blood malignancy, has complex and costly disease management. We studied patterns of treatment disparities and unplanned interruptions among the MM patients after the Affordable Care Act to assess their prevalence and effect on survival. MATERIALS AND METHODS: This retrospective study of 1002 MM patients at a tertiary referral center used standard guidelines as a reference to identify underuse of effective treatments. We used multivariate logistic regression and Cox proportionate hazard to study the prognostic effect on survival. RESULTS: Median age in the cohort was 63.0 [IQR: 14] years. Non-Hispanic White (NHW) patients were older (p = 0.007) and more likely to present with stage I disease (p = 0.02). Underuse of maintenance therapy (aOR = 1.98; 95 % CI 1.12-3.48) and interruptions in treatment were associated with race/ethnicity and insurance (aOR = 4.14; 95 % CI: 1.78-9.74). Only underuse of induction therapy was associated with overall patient survival. CONCLUSION: Age, race, ethnicity and primary insurance contribute to the underuse of treatment and in unplanned interruptions in MM treatment. Addressing underuse causes in such patients is warranted.


Subject(s)
Healthcare Disparities , Multiple Myeloma , Aged , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , Humans , Insurance, Health/statistics & numerical data , Middle Aged , Multiple Myeloma/epidemiology , Multiple Myeloma/ethnology , Multiple Myeloma/therapy , Patient Protection and Affordable Care Act , Racial Groups/statistics & numerical data , Retrospective Studies , United States/epidemiology
9.
Cancer Epidemiol ; 73: 101972, 2021 08.
Article in English | MEDLINE | ID: mdl-34216957

ABSTRACT

BACKGROUND: Aberrant Wnt/beta-catenin pathway activation is implicated in Multiple Myeloma (MM) development, but little is known if genetic variants within this pathway contribute to MM susceptibility. METHODS: We performed a discovery candidate pathway analysis in 269 non-Hispanic white MM cases and 272 controls focusing on 171 variants selected from 26 core genes within the Wnt/beta-catenin pathway. Significant candidate variants (P < 0.05) were selected for validation in internal and external non-Hispanic white populations totaling 818 cases and 1209 controls. We also examined significant variants in non-Hispanic black and Hispanic case/control study populations to identify potential differences by race/ethnicity. Possible biological functions of candidate variants were predicted in silico. RESULTS: Seven variants were significantly associated with MM risk in non-Hispanic whites in the discovery population, of which LRP6:rs7966410 (OR: 0.57; 95 % CI: 0.38-0.88; P = 9.90 × 10-3) and LRP6:rs7956971 (OR: 0.64; 95 % CI: 0.44-0.95; P = 0.027) remained significant in the internal and external populations. CSNK1D:rs9901910 replicated among all three racial/ethnic groups, with 2-6 fold increased risk of MM (OR: 2.40; 95 % CI: 1.67-3.45; P = 2.43 × 10-6 - non-Hispanic white; OR: 6.42; 95 % CI: 2.47-16.7; P = 3.14 × 10-4 - non-Hispanic black; OR: 4.31; 95 % CI: 1.83-10.1; P = 8.10 × 10-4 - Hispanic). BTRC:rs7916830 was associated with a significant 37 % and 24 % reduced risk of MM in the non-Hispanic white (95 % CI: 0.49-0.82; P = 5.60 × 10-4) and non-Hispanic Black (95 % CI: 0.60-0.97; P = 0.028) population, respectively. In silico tools predicted that these loci altered function through via gene regulation. CONCLUSION: We identified several variants within the Wnt/beta-catenin pathway associated with MM susceptibility. Findings of this study highlight the potential genetic role of Wnt/beta-catenin signaling in MM etiology among a diverse patient population.


Subject(s)
Multiple Myeloma , Wnt Signaling Pathway , beta Catenin , Black or African American/genetics , Black or African American/statistics & numerical data , Aged , Case-Control Studies , Female , Genetic Predisposition to Disease/ethnology , Hispanic or Latino/genetics , Hispanic or Latino/statistics & numerical data , Humans , Male , Middle Aged , Multiple Myeloma/ethnology , Multiple Myeloma/genetics , White People/genetics , White People/statistics & numerical data , Wnt Signaling Pathway/genetics , beta Catenin/genetics
10.
PLoS One ; 16(6): e0253541, 2021.
Article in English | MEDLINE | ID: mdl-34166440

ABSTRACT

INTRODUCTION: We assessed the applicability of next-generation sequencing (NGS)-based IGH/IGK clonality testing and analyzed the repertoire of immunoglobulin heavy chain (IGH) or immunoglobulin kappa light chain (IGK) gene usage in Korean patients with multiple myeloma (MM) for the first time. METHODS: Fifty-nine bone marrow samples from 57 Korean patients with MM were analyzed, and NGS-based clonality testing that targeted the IGH and IGK genes was performed using IGH FR1 and IGK primer sets. RESULTS: Clonal IGH and IGK rearrangements were observed in 74.2% and 67.7% of samples from Korean patients with kappa-restricted MM, respectively (90.3% had one or both), and in 60.7% and 95.5% of samples from those with lambda-restricted MM, respectively (85.7% had one or both). In total, 88.1% of samples from Koreans with MM had clonal IGH and/or IGK rearrangement. Clonal rearrangement was not significantly associated with the bone marrow plasma cells as a proportion of all BM lymphoid cells. IGHV3-9 (11.63%) and IGHV4-31 (9.30%) were the most frequently reported IGHV genes and were more common in Koreans with MM than in Western counterparts. IGHD3-10 and IGHD3-3 (13.95% each) were the most frequent IGHD genes; IGHD3-3 was more common in Koreans with MM. No IGK rearrangement was particularly prevalent, but single IGKV-J rearrangements were less common in Koreans with kappa-restricted MM than in Western counterparts. IGKV4-1 was less frequent in Koreans regardless of light chain type. Otherwise, the usages of the IGH V, D, and J genes and of the IGK gene were like those observed in previous Western studies. CONCLUSION: NGS-based IGH/IGK clonality testing ought to be applicable to most Koreans with MM. The overrepresentation of IGHV3-9, IGHV4-31, and IGHD3-3 along with the underrepresentation of IGKV4-1 and the differences in IGK gene rearrangement types suggest the existence of ethnicity-specific variations in this disease.


Subject(s)
Gene Rearrangement, B-Lymphocyte , Immunoglobulin Heavy Chains , Immunoglobulin kappa-Chains/genetics , Neoplasm Proteins , Adult , Aged , Aged, 80 and over , Asian People , Female , High-Throughput Nucleotide Sequencing , Humans , Male , Middle Aged , Multiple Myeloma/ethnology , Multiple Myeloma/genetics , Republic of Korea/ethnology
11.
Clin Lymphoma Myeloma Leuk ; 21(8): e680-e685, 2021 08.
Article in English | MEDLINE | ID: mdl-34148850

ABSTRACT

BACKGROUND: Most guidelines recommend induction therapy followed by autologous hematopoietic cell transplantation. A Surveillance, Epidemiology, and End Results-Medicare database analysis from 2000 to 2011 noted a lower use of HCT and bortezomib among Black patients, despite adjusting for care barriers, and this practice was associated with a poorer outcome. The goal of this study was to evaluate patterns of acceptance of HCT as consolidative therapy for MM. METHODS: Cox proportional hazards model was used to investigate the association between the survival time of the patients (overall survival) and age of the diagnosis, race, socioeconomic status, disease cytogenetic, and initial induction regimens. A total of 194 patients with a confirmed diagnosis of MM who were referred for HCT between January 1, 2009, and June 30, 2019, were included in this study. Patients who received autologous stem cell transplant for relapsed MM were excluded. RESULTS: We found that income category was not significantly associated with overall survival, time to transplant or transplant-/relapse-related mortality. High-risk cytogenetic was significantly associated with shorter overall survival, higher transplant-related mortality and relapse-related mortality (P < .002). The use of aggressive induction choices was associated with poorer transplant outcomes (P = .02). Time to transplant tended to be shorter in African American compared with other ethnic groups (P = .07). CONCLUSION: There was no significant difference in the use rate of the HCT between Caucasians and AA patients with MM. Further comparative studies of MM induction therapy and access to clinical trials in African Americans and other racial minorities are warranted.


Subject(s)
Hematopoietic Stem Cell Transplantation/ethnology , Multiple Myeloma/ethnology , Multiple Myeloma/surgery , Black or African American , Aged , Female , Hematopoietic Stem Cell Transplantation/mortality , Humans , Induction Chemotherapy , Male , Middle Aged , Multiple Myeloma/drug therapy , Multiple Myeloma/mortality , Patient Acceptance of Health Care/ethnology , Proportional Hazards Models , Retrospective Studies , Risk Factors , Time-to-Treatment , Transplantation, Autologous , United States , White People
12.
J Clin Apher ; 36(4): 634-644, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34046928

ABSTRACT

BACKGROUND: Whether race/ethnicity plays a role in hematopoietic stem/progenitor cells (HSPC) mobilization in autologous donors has not been studied. We hypothesize that donor characteristic including race/ethnicity, age, sex, body mass index, and diagnostic groups influences HSPC mobilization. Diagnostic groups include healthy allogeneic donors, autologous multiple myeloma (MM) and non-MM donors. STUDY DESIGN AND METHODS: Here, we conducted a single-center retrospective study in 64 autologous patients and 48 allogeneic donors. Autologous donors were patients diagnosed with MM or non-MM. All donors were grouped as African American (AA), White (W), or "Other"(O). RESULTS: Multivariate analysis demonstrated diagnostic group differences for CD34+ cell yields between race/ethnicity. Specifically, non-MM patients had the lowest CD34+ cell yields in AA and O, but not in W. For pre-apheresis peripheral blood (PB) CD34+ cell numbers, race/ethnicity had a significant effect both in bivariate and multivariate analyses. Non-MM patients had the lowest, and AA patients had the highest PB CD34+ cells. The results support the view that past therapies used in MM are likely more conducive of recovery of HSPC. CONCLUSIONS: Our study shows that race/ethnicity and diagnostic group differences influenced CD34+ cell mobilization response across donor types. Interestingly, autologous MM donors with the aid of plerixafor displayed comparable CD34 yields to allogeneic donors. Even though both MM and non-MM donors received plerixafor, non-MM donors had significantly lower CD34 yields among AA and O donors but not in W donors. Larger studies would be required to validate the role of diagnostic groups and race/ethnicity interactions.


Subject(s)
Hematopoietic Stem Cell Mobilization/methods , Hematopoietic Stem Cells/cytology , Multiple Myeloma/ethnology , Multiple Myeloma/therapy , Stem Cells/cytology , Adult , Black or African American , Aged , Antigens, CD34/metabolism , Blood Component Removal , Body Mass Index , Ethnicity , Female , Granulocyte Colony-Stimulating Factor/pharmacology , Hematopoietic Stem Cell Transplantation , Humans , Male , Middle Aged , Multivariate Analysis , Retrospective Studies , Transplantation, Autologous , Transplantation, Homologous , United States
13.
Ann Hematol ; 100(4): 1065-1077, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33599794

ABSTRACT

The phase 3 COLUMBA study demonstrated noninferiority of subcutaneous daratumumab (DARA SC) to intravenous daratumumab (DARA IV) in relapsed or refractory multiple myeloma. We present a subgroup analysis of Asian patients from COLUMBA. Eligible patients had ≥ 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or were double refractory. Co-primary endpoints were overall response rate (ORR) and maximum trough concentration (Ctrough). Secondary endpoints included rates of infusion-related reactions, progression-free survival, and patient-reported satisfaction with therapy. Sixty-seven Asian patients (DARA SC, n = 30; DARA IV, n = 37) were randomized, including 42 Japanese patients (DARA SC, n = 18; DARA IV, n = 24). Comparable ORRs for DARA SC versus DARA IV were seen in the Asian cohort (66.7% vs 43.2%) and Japanese-only cohort (61.1% vs 54.2%), including patients weighing ≤ 65 kg. Similarity of Ctrough was seen in both Asian and Japanese-only cohorts; the ratio of the geometric mean of the Ctrough concentrations for DARA SC/DARA IV was 143.96% (90% confidence interval (CI), 112.03-185.00%) and 148.02% (90% CI, 113.32-193.34%), respectively. The Asian cohort (both treatment groups) and Japanese-only cohort (DARA SC group) experienced higher rates of grade 3/4 cytopenias compared with the global COLUMBA population, occurring predominantly in patients of low bodyweight; no patients discontinued treatment due to cytopenias. The Cancer Therapy Satisfaction Questionnaire results generally favored DARA SC. In the Asian and Japanese-only cohorts, DARA SC was comparable to DARA IV. The efficacy, pharmacokinetic, safety, and satisfaction results were generally consistent with the global COLUMBA population regardless of patient bodyweight. ClinicalTrials.gov Identifier: NCT03277105.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Asian People/statistics & numerical data , Multiple Myeloma/drug therapy , Salvage Therapy , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal/pharmacokinetics , Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Agents, Immunological/pharmacokinetics , Asian People/psychology , Body Weight , Disease-Free Survival , Female , Follow-Up Studies , Humans , Injections, Subcutaneous , Japan/epidemiology , Kaplan-Meier Estimate , Male , Middle Aged , Multiple Myeloma/ethnology , Multiple Myeloma/mortality , Multiple Myeloma/therapy , Neutropenia/chemically induced , Patient Satisfaction , Progression-Free Survival , Republic of Korea/epidemiology , Taiwan/epidemiology , Young Adult
14.
Cancer Med ; 10(1): 386-395, 2021 01.
Article in English | MEDLINE | ID: mdl-33270992

ABSTRACT

Plasma cell myeloma (also called multiple myeloma), solitary plasmacytoma, and extramedullary plasmacytoma are primarily diseases of the elderly. Evidence suggests an association between excess body weight and multiple myeloma. Few population-based studies have examined incidence and mortality of each site in one study. We analyzed incidence and death rates by site (solitary plasmacytoma, extramedullary plasmacytoma, and multiple myeloma) by gender, age, race/ethnicity, and rural-urban status among adult males and females (aged 20 years or older) in the United States during 2003-2016. Trends were characterized as average annual percentage change (AAPC) in rates. During 2003-2016, overall incidence rates among adults were 0.45 for solitary plasmacytoma, 0.09 for extramedullary plasmacytoma, and 8.47 for multiple myeloma per 100,000 persons. Incidence rates for multiple myeloma increased during 2003-2016 among non-Hispanic whites (AAPC = 1.78%) and non-Hispanic blacks (2.98%) 20-49 years of age; non-Hispanic whites (1.17%) and non-Hispanic blacks (1.24%) 50-59 years of age; and whites non-Hispanic (0.91%), and non-Hispanic blacks (0.96%). During 2003-2016 overall myeloma (extramedullary plasmacytoma and multiple myeloma) death rates among adults was 4.77 per 100,00 persons. Myeloma death rates decreased during 2003-2016 among non-Hispanic white (AAPC = -1.23%) and Hispanic (-1.34%) women; and non-Hispanic white (-0.74%), non-Hispanic American Indian/Alaska Native (-3.05%) men. The US population is projected to become older and will have a larger proportion of persons who have had an earlier and longer exposure to excess body weight. The potential impact of these population changes on myeloma incidence and mortality can be monitored with high-quality cancer surveillance data.


Subject(s)
Multiple Myeloma/ethnology , Plasmacytoma/ethnology , Racial Groups , Adult , Black or African American , Age Factors , Aged , Aged, 80 and over , American Indian or Alaska Native , Female , Hispanic or Latino , Humans , Incidence , Male , Middle Aged , Multiple Myeloma/diagnosis , Multiple Myeloma/mortality , Obesity/ethnology , Plasmacytoma/diagnosis , Plasmacytoma/mortality , Race Factors , Risk Assessment , Risk Factors , Rural Health , Sex Factors , Time Factors , United States/epidemiology , Urban Health , White People , Young Adult
15.
Cancer ; 126(19): 4332-4340, 2020 10 01.
Article in English | MEDLINE | ID: mdl-32706404

ABSTRACT

BACKGROUND: Studies have reported racial disparities in access to and use of multiple myeloma (MM) treatments between African American (AA) and White patients. Although AA patients demonstrate longer disease-specific survival, this has not uniformly translated into improved survival over time. The association between race and treatment patterns and survival outcomes was analyzed using data from the Connect MM Registry. METHODS: The Connect MM Registry is a large US, multicenter, prospective observational cohort study of patients with newly diagnosed MM. Patients who received first-line (1L) stem cell transplantation (SCT) or who did not receive SCT (non-SCT or non-stem cell transplantation [NSCT]) were grouped by raceEffects of race and transplantation status on the use of triplet treatment were estimated using logistic regression. RESULTS: Treatment patterns in 1L (types and duration of induction, posttransplantation maintenance) were similar between AA and White patients. SCT rates in 1L (32% vs 36%) and triplet treatment use (AA: 44% for NSCT patients and 72% for SCT patients; and White: 48% for NSCT patients and 72% for SCT patients) during first induction were similar. No significant effect of race or transplantation status on 1L triplet treatment use was observed. Race was not found to be associated with survival outcomes among patients who underwent NSCT; however, AA patients who received SCT had significantly longer overall survival compared with White patients who underwent SCT (not reached vs 88.2 months; hazard ratio, 0.56; 95% CI, 0.35-0.89 [P = .0141]). CONCLUSIONS: AA and White patients were found to have similar treatment patterns in the Connect MM Registry, suggesting that both groups had equal access to health care. In this real-world setting, AA patients received standard-of-care treatment, which might have contributed to better MM-specific survival compared with White patients.


Subject(s)
Multiple Myeloma/ethnology , Multiple Myeloma/mortality , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Racial Groups , Registries , Survival Analysis , United States , Young Adult
16.
Ann Epidemiol ; 48: 43-50.e4, 2020 08.
Article in English | MEDLINE | ID: mdl-32620423

ABSTRACT

PURPOSE: To visualize variation in multiple myeloma (MM) incidence and mortality rates by race-ethnicity and geographic location and evaluate their correlation with neighborhood-level population covariates within New York City (NYC). METHODS: Trends and racial differences in MM incidence and mortality for the United States [Surveillance, Epidemiology, and End Results Cancer Registry (SEER), National Center for Health Statistics], and NYC [New York State Cancer Registry] were compared using Joinpoint regression. Pearson's correlation coefficients measured neighborhood-level MM-covariate relationships (n = 34). RESULTS: MM incidence rates are double in African-Americans compared with Whites, in SEER-13 areas (rate ratio (RR) = 2.27; 95% confidence interval [CI] = 2.22-2.32) and NYC (RR = 2.11; 95% CI = 2.03-2.20). Incidence rates increased faster in NYC (average annual percentage change difference, -1.1; 95% CI, -2.3 to -0.1). NYC African-American men experienced the steepest increase in mortality rates after 2001. In NYC, strong neighborhood-level correlations exist between incidence and mortality rates and high prevalence of residents of African ancestry, Latin American birth, daily sugary beverage and low fruit and vegetable consumption, and neighborhood walkability. Higher MM mortality also correlates with Hispanic ethnicity, obesity, diabetes, poverty, HIV/AIDS, air benzene concentration, and indoor pesticide use. CONCLUSIONS: NYC neighborhoods with large minority populations have higher prevalence of poverty-related factors associated with MM incidence and mortality, warranting public health policies to address exposures and access to care.


Subject(s)
Black or African American/statistics & numerical data , Health Services Accessibility , Health Status Disparities , Mortality/ethnology , Multiple Myeloma/ethnology , Residence Characteristics , Social Determinants of Health , White People/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Ethnicity , Female , Humans , Incidence , Male , Middle Aged , Mortality/trends , Multiple Myeloma/diagnosis , New York City/epidemiology , Population Surveillance/methods , Poverty , Socioeconomic Factors , United States/epidemiology , Young Adult
17.
Blood Cancer J ; 10(2): 19, 2020 02 17.
Article in English | MEDLINE | ID: mdl-32066732

ABSTRACT

Multiple myeloma (MM) is a fatal plasma cell dyscrasia with a median overall survival of 5 to 10 years. MM progresses from the more common but often subclinical precursor states of monoclonal gammopathy of undetermined significance (MGUS), and smoldering multiple myeloma (SMM) to overt MM. There are large racial disparities in all stages of the disease. Compared with Whites, Blacks have an increased MGUS and MM risk and higher mortality rate, and have not experienced the same survival gains over time. The roots of this disparity are likely multifactorial in nature. Comparisons of Black and White MGUS and MM patients suggest that differences in risk factors, biology, and clinical characteristics exist by race or ancestry, which may explain some of the observed disparity in MM. However, poor accrual of Black MGUS and MM patients in clinical and epidemiological studies has limited our understanding of this disparity and hindered its elimination. Disparities in MM survival also exist but appear to stem from inferior treatment utilization and access rather than underlying pathogenesis. Innovative and multidisciplinary approaches are urgently needed to enhance our understanding of disparities that exist at each stage of the MM disease continuum and facilitate their elimination.


Subject(s)
Health Status Disparities , Healthcare Disparities/statistics & numerical data , Multiple Myeloma/ethnology , Multiple Myeloma/therapy , Humans
18.
Clin Lymphoma Myeloma Leuk ; 19(10): 619-623, 2019 10.
Article in English | MEDLINE | ID: mdl-31377212

ABSTRACT

INTRODUCTION: Outcomes in multiple myeloma (MM) have improved significantly over time. This is true overall for all patients as well as patient subgroups based on age and race/ethnicity. Despite this, disparities are noted in outcomes when looking at racial subgroups. MATERIALS AND METHODS: We performed an analysis from the population-based Surveillance, Epidemiology, and End Results (SEER) database to evaluate improvement in relative survival rates (RSRs) for young (≤ 40 years at the time of MM diagnosis) and older (> 40 years at the time of MM diagnosis) over time by race/ethnicity, specifically focusing on Hispanic patients with MM. Expected survival was estimated using the age- and gender-specific death rates from the United States population. RSR was provided as the ratio of the observed to expected survival at individual time points. Five-year and 10-year RSRs were calculated for patients based on treatments modalities available in various time periods. RESULTS: We identified a total of 89,451 patients with MM in SEER, of which 1460 patients formed the young patients with MM (≤ 40 years) cohort. Five- and 10-year RSR improved significantly over time for all patients and older patients (> 40 years) by race (all P < .001). Evaluating the younger patients, RSR improved significantly for non-Hispanic whites and non-Hispanic blacks, but not for Hispanics. This was true for the 5-year (P = .08) and 10-year (P = .13) RSRs. CONCLUSION: We report a lack of significant benefit in long-term outcomes for younger Hispanic patients with MM over time. This could be owing to multifactorial causes that need to be addressed to mitigate outcome disparities.


Subject(s)
Healthcare Disparities/statistics & numerical data , Multiple Myeloma/therapy , Population Surveillance/methods , SEER Program/statistics & numerical data , Adult , Black or African American/statistics & numerical data , Age Factors , Aged , Asian People/statistics & numerical data , Cohort Studies , Female , Healthcare Disparities/trends , Hispanic or Latino/statistics & numerical data , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Multiple Myeloma/diagnosis , Multiple Myeloma/ethnology , United States , White People/statistics & numerical data
19.
Clin Lymphoma Myeloma Leuk ; 19(8): e506-e511, 2019 08.
Article in English | MEDLINE | ID: mdl-31231013

ABSTRACT

INTRODUCTION/BACKGROUND: African American (AA) individuals have a twofold higher incidence of multiple myeloma (MM) compared with other racial groups. Outcomes are affected by factors such as disparate access to care as well as differences in disease biology. PATIENTS AND METHODS: We conducted a single-institution analysis to evaluate the effect of AA race on outcomes of MM patients who underwent autologous stem cell transplantation (ASCT) in the pre-novel and novel agent era. RESULTS: Sixty-one (47%) patients were AA and 69 (53%) were non-AA. Overall, 78 (60%) patients received any novel agent before transplantation and 52 (40%) received only chemotherapy. More non-AA patients received initial induction with a proteasome inhibitor (40 [60%] vs. 17 [28%]; P = .0007), and were treated with post-ASCT maintenance therapy (28 [41%] vs. 14 [23%]; P = .04). Time from diagnosis to ASCT in AA patients was 10 (range, 4-144) versus 8 (range, 3-54) months in non-AA patients (P = .01). Despite this, treatment-free survival (TFS) was equivalent between the 2 groups (x vs. y). Furthermore, AA patients had greater median overall survival (OS) compared with non-AA patients (not reached vs. 108 months; P = .03) and significantly improved OS in multivariable Cox proportional hazards models (adjusted hazard ratio, 0.30; 95% confidence interval, 0.11-0.81; P = .017). Median OS, landmarked at the time of relapse, was improved in AA patients (not reached vs. 68 months for P = .05). CONCLUSION: Our study showed with long follow-up, equivalent TFS after ASCT in AA and non-AA patients yet improved OS. Post relapse survival is improved in AA patients suggesting a better response to salvage therapy.


Subject(s)
Black or African American/statistics & numerical data , Multiple Myeloma/mortality , Neoplasm Recurrence, Local/mortality , Salvage Therapy , Stem Cell Transplantation/mortality , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Multiple Myeloma/ethnology , Multiple Myeloma/pathology , Multiple Myeloma/therapy , Neoplasm Recurrence, Local/ethnology , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/therapy , Prognosis , Retrospective Studies , Survival Rate , Transplantation, Autologous , White People/statistics & numerical data
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