Treatment response among patients with multiple myeloma initiating daratumumab across different lines of therapy: A real-world chart review study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18737-e18737
Author(s):  
Shebli Atrash ◽  
Philippe Thompson-Leduc ◽  
Ming-Hui Tai ◽  
Shuchita Kaila ◽  
Kathleen Gray ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Treatment Response ◽  
Real World ◽  
Chart Review ◽  
Response Rate ◽  
Retrospective Chart Review ◽  
Case Report Form ◽  
Combination Regimen ◽  
Cell Transplant ◽  
Effective Treatment Option

e18737 Background: Daratumumab (DARA), a CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma (MM) among previously-treated patients since 2015, and among newly-diagnosed patients since 2018. This study aimed to describe real-world treatment response among patients initiating DARA across different lines of therapy since 2018. Methods: A retrospective chart review of adult patients with MM initiating DARA (monotherapy or as part of a combination regimen) between 1/2018 and 5/2020 was conducted at two clinical sites in the US (Levine Cancer Institute & Weill Cornell Medical College). De-identified patient-level data were abstracted in an electronic case report form. Treatment patterns, overall response rate (ORR) and proportion of patients with very good partial response (VGPR) or better were reported using descriptive statistics and stratified by line of therapy (first line [1L], second line [2L] or third line or later [3L+]). Results: A total of 202 patient charts were extracted. Patients were, on average, 65.3 years old at MM diagnosis and 68.1 years old at DARA initiation; 109 (54.0%) were male; 104 (51.5%) were White and 65 (32.2%) were Black or African American; 64 (31.7%) received a stem cell transplant (SCT) prior to the line of DARA initiation. Twenty-one (10.4%), 53 (26.2%) and 128 (63.4%) patients initiated DARA in 1L, 2L and 3L+, respectively. Median follow-up time was 6.2 months for 1L patients and 13.8 months for 2L+ patients. The most common 1L regimen was DARA with bortezomib, lenalidomide ± dexamethasone (DVRd; n=10, 47.6%) followed by DARA with lenalidomide ± dexamethasone (DRd; n=8, 38.1%). The most common 2L regimen was DRd (n=15, 28.3%) followed by DARA with pomalidomide ± dexamethasone (DPd, n=13, 24.5%) and DARA with bortezomib ± dexamethasone (DVd, n=13, 24.5%). The most common regimen in 3L+ was DPd (n=62, 48.4%). Among patients initiating DARA in 1L, 2L or 3L+ the ORR was 100.0%, 81.6% and 76.0%, and the proportion of patients achieving VGPR or better was 73.3%, 65.8% and 51.0%, respectively (Table 1). Median time to treatment response ranged between 2.6 and 2.8 months post-initiation. Conclusions: In this study, patients initiated on DARA had high ORR and rates of VGPR or better, including an ORR of 100% among 1L DARA users. These findings suggest that DARA-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1L. [Table: see text]

scholarly journals Treatment patterns and effectiveness of patients with multiple myeloma initiating Daratumumab across different lines of therapy: a real-world chart review study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shebli ATRASH ◽  
Philippe THOMPSON-LEDUC ◽  
Ming-Hui TAI ◽  
Shuchita KAILA ◽  
Kathleen GRAY ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Outcomes ◽  
Real World ◽  
Chart Review ◽  
Response Rate ◽  
Progression Free Survival ◽  
Treatment Patterns ◽  
Free Survival ◽  
Kaplan Meier ◽  
Line Of Therapy

Abstract Background Daratumumab, a CD38 monoclonal antibody, has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly-diagnosed and refractory patients with multiple myeloma (MM). However, there is limited evidence on treatment patterns and effectiveness of daratumumab in the real-world setting, particularly in first line (1 L). This study aimed to describe real-world treatment patterns and clinical outcomes among patients initiating daratumumab across different lines of therapy. Methods A retrospective chart review of adult patients with MM initiating daratumumab between November 2015 and March 2021 was conducted at two clinical sites in the United States. De-identified patient-level data were abstracted in an electronic case report form. Patient characteristics and treatment patterns were described. Clinical outcomes including overall response rate (ORR), progression-free survival, and time to next line of therapy were reported using descriptive statistics and stratified by line of therapy (1 L, second line [2 L] or third line or later [3 L+]). A sub-group analysis evaluated treatment patterns and ORR among patients re-treated with daratumumab. Results A total of 299 patients were included in the study (mean age: 68 years; 55% male). Among them, 26 were 1 L patients, 66 were 2 L patients, and 207 were 3 L+ patients; 110 patients (36.8%) received a stem cell transplant prior to daratumumab initiation. The mean duration of follow-up was 10 months among 1 L patients and 19 months among 2 L and 3 L+ patients. Patients who initiated daratumumab in 1 L had a 100% ORR, while those initiating in 2 L and 3 L+ had an ORR of 78.8 and 65.2%, respectively. Among re-treated patients, ORR was 66.7% during the first treatment segment, and 52.9% during the second treatment segment. Kaplan-Meier rates of progression-free survival at 12 months were 89.9, 75.2, and 53.1% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Kaplan-Meier rates of time to next line of therapy at 12 months were 94.1, 73.4, and 50.0% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Conclusions These findings suggest that daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1 L.

scholarly journals Daratumumab, Pomalidomide, and Dexamethasone (DPd) for the Treatment of Relapsed/Refractory Multiple Myeloma: A Single Institution Experience

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5642-5642 ◽  
Author(s):  
Al-Ola Abdallah ◽  
Neil Dunavin ◽  
Brian McClune ◽  
Leyla Shune ◽  
Ajoy L. Dias ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Proteasome Inhibitor ◽  
Research Funding ◽  
Median Number ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Duration Of Treatment ◽  
Effective Treatment Option ◽  
Refractory Multiple Myeloma ◽  
Overall Response

Abstract Background: Daratumumab triplet regimens containing dexamethasone and lenalidomide or bortezomib are an effective treatment option for patients with relapsed/refractory multiple myeloma (RRMM). Daratumumab was recently FDA-approved in combination with the second-generation immunomodulatory drug, pomalidomide, and dexamethasone based (DPd) on results of the EQUULEUS study where overall response rates (ORR) of 60% were seen. The goal of this retrospective study was to analyze clinical outcomes of the DPd triplet regimen in either a daratumumab and pomalidomide naïve or refractory population of heavily pretreated RRMM patients at our institution. Methods: Thirty-two patients with RRMM treated with DPd at the University of Kansas Health System between November 2015 and July 2018 were included in our analysis. DPd consisted of 28-day cycles of daratumumab 16 mg/kg intravenously (weekly for cycles 1 and 2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression); pomalidomide 4 mg orally (PO)on Days 1-21 and adjusted for cytopenia or toxicities; and dexamethasone 40 mg PO weekly adjusted based on tolerance. based on age. Responses were evaluated using IMWG criteria. Patient characteristics, disease course, and outcomes were summarized with descriptive statistics. Kaplan-Meier analyses were used to estimate progression-free (PFS) and overall survival (OS). Results:The median age was 64 years (range 44-83). Twenty-three patients (72%) had IgG isotype, 11 patients (34 %) had ISS stage III disease at diagnosis, 13 patients (41%) had high risk cytogenetics, and 13 patients (41%) had extramedullary disease. Median number of previous lines of therapy was 4 (1-9). Twenty-two patients (69%) received ≥3 prior therapies. Twenty-three patients (72%) were proteasome inhibitor refractory, 28 patients (88%) were immunomodulator refractory, 9 patients (28%) were daratumumab refractory, and 3 patients (15%) were double refractory to daratumumab and pomalidomide. Twenty-eight patients (88%) had received autologous stem cell transplant (ASCT) prior to DPd; 12 patients (38%) had ≥2 prior transplants. Median number of DPd cycles received was 6 (2-30) and the median duration of treatment was 5 months (2-30). At a median follow-up of 8.4 months (range: 2-29), the overall response rate (ORR) for all patients was 72% which compares favorably to the ORR of 60% in the EQUULEUS study. However, about half of the responses were partial responses (PR) (47%). The ORR rate for those who were refractory to either pomalidomide or daratumumab was 65%. The PFS was 8.3 months, while the median OS was not reached. Conclusion: DPd was recently approved for the treatment of RRMM. Our ORR compares favorably to the EQUULEUS study, however about half of responses were partial responses or better. Surprisingly, our analysis shows an impressive ORR in patients with previous exposure to proteasome inhibitor and immunomodulatory therapies in RRMM population, suggesting a benefit of DPd even in patients who received prior pomalidomide or daratumumab. Disclosures McGuirk: Astellas Pharma: Research Funding; Gamida Cell: Research Funding; Novartis Pharmaceuticals Corporation: Honoraria, Other: speaker, Research Funding; Pluristem Ltd: Research Funding; Kite Pharma: Honoraria, Other: travel accommodations, expenses, speaker ; Fresenius Biotech: Research Funding; Bellicum Pharmaceuticals: Research Funding. Ganguly:Daiichi Sankyo: Research Funding; Janssen: Consultancy; Amgen: Consultancy; Seattle Genetics: Speakers Bureau.

Interim Results of An Ongoing Clinical Study Suggests Efficacy and Improved Toxicity Profile with Once a Week Bortezomib with Dexamethasone In Newly Diagnosed Multiple Myeloma Patients with Older Age and Co-Morbidities

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3061-3061 ◽  
Author(s):  
Nikhil C. Munshi ◽  
Saem Lee ◽  
Suman Kambhampati ◽  
Abid Mohiuddin ◽  
Michal Rose ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Board Of Directors ◽  
Overall Response Rate ◽  
Response Rate ◽  
Previous History ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Current Time ◽  
Overall Response

Abstract Abstract 3061 The current bortezomib schedule involves administration of the drug twice a week at 1.3 mg/m2 for 2 weeks every 21 days. This regimen although effective is inconvenient and associated with side effects including neuropathy and gastrointestinal toxicities that limits its use in a proportion of patients. Therefore, to improve convenience and compliance, we have investigated efficacy and safety of a weekly regimen of bortezomib. In this one-stage phase II multi-center, open-label single-arm study bortezomib is administered once a week at 1.6 mg/m2 in combination with dexamethasone in newly-diagnosed multiple myeloma patients not considered for autologous stem cell transplant in participating Veterans Hospitals nationwide. The objective is to evaluate overall response rate and toxicity of this regimen. Patients received bortezomib at 1.6 mg/m2 IV weekly for 4 weeks followed by 1 week off and dexamethasone 40mg PO on the day of and day after each dose of bortezomib. Patients may receive 6 such 5-week cycles. At the current time 32 patients (median age - 73; range 50–88) have been enrolled at 11 Veterans Administration Hospital across the U.S. Patients had significant co-morbidities including 61% with cardiovascular problems, 58% with diabetes and/or hyperlipidemia, 58% with elevation of serum creatinine, 26% with respiratory problems and 23% with previous history of cancer. All patients were at least on 5 daily medications. Of the 32 patients enrolled, 25 patients have received at least one cycle of therapy and were evaluable for toxicity and efficacy, while 6 patients have received less than one cycle of therapy and one patient has inadequate data. With a median of 4 cycles administered, this regimen was well tolerated. None of the patients have developed grade 3 neuropathy, while grade 1 neuropathy was observed only in 2 patients and one patient with grade 1 neuropathy at diagnosis had increase to grade 2. Dexamethasone dose was reduced in 29% patients while 6% required reduction in bortezomib dose to 1.3 mg/m2. Additionally, Grade ≥1 asthenia was observed in 42%, diarrhea in 35%, and thrombocytopenia in 26%. Four patients have died of co-morbidities which were considered unrelated or probably unrelated to the treatment with bortezomib. The partial response or better was achieved in 68% patients receiving at least 1 cycle of therapy; 20% patients achieved CR/nCR and additional 12% achieved VGPR. Including MR in the analysis, overall response was observed in all evaluable patients. On intent to treat analysis including all 32 patients, overall response rate (≥ MR) was observed in 78% patients and PR or better in 53% patients. These preliminary results suggest that the once a week bortezomib regimen is effective and tolerable with reduced toxicity even in this older patient population with significant co-morbidities. Disclosures: Munshi: Millennium: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Onyx: Consultancy, Membership on an entity's Board of Directors or advisory committees. Roodman:Millennium: Consultancy; Amgen: Consultancy, Honoraria; Novartis: Honoraria, Research Funding; Celgene: Honoraria.

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