Initial Results from the ASH Research Collaborative's COVID-19 Outcomes in Myeloma and the Impact of Vaccines (COSMIC): A Decentralized, Real-World Evidence Study for Patients with Multiple Myeloma to Monitor Outcomes Related to COVID-19 Vaccines and Infections

Background: Data from the ASH Research Collaborative COVID-19 Registry for Hematology demonstrated that patients with multiple myeloma and other immune compromise had elevated risk for severe complications from COVID-19 infection. To address current evidence gaps and to demonstrate proof of concept for a pandemic preparedness and response network, the ASH Research Collaborative Multiple Myeloma Program developed a prospective, decentralized study within a site-based provider network to investigate COVID-19 infections, vaccinations, and quality of life in patients with multiple myeloma.

Methods: We designed and established the COVID-19 OutcomeS in Myeloma and the Impact of VacCines (COSMIC) to study COVID-19 in patients with multiple myeloma at ASH Research Collaborative network sites. A study application was accessed with a QR code and shared with patients during usual clinical care. Patients provided consent, optionally gave permission for electronic health record data collection, and completed patient-reported outcomes (EORTC QLQ-C30 and MY20) at baseline, Day 30, and Day 180 through the study portal. Clinicians at participating sites facilitated study enrollment and shared best practices monthly to accelerate study execution. Study objectives related to feasibility of data collection in a decentralized format are reported in a separate abstract. Here, we report interim results related to SARS-CoV-2 vaccination history, COVID-19 infection, and how these relate to patient reported outcomes and clinical outcomes in enrolled participants.

Results: The COSMIC study rapidly accrued and consented 200 patients from eight participating ASH Research Collaborative sites over four months (1/22/2024 through 5/17/2024). Consented participants' ages ranged from 29 to 93 years, with median of 67 years; 46% were female, 69% were non-Hispanic White (NHW), 17% were non-Hispanic Black (NHB), and 8% were Hispanic/Latino. Of the 196 patients who reported COVID-19 data, 111 (57%) reported at baseline that they had a history of COVID-19 infection, with 12 having required hospitalization for this (12/111=11%). Overall, 95% (186/196) reported a history of COVID-19 vaccination, where the median number of vaccinations was 4 (range: 1 to 6); 44 patients (23%) expressed willingness to discuss getting a yearly booster vaccine with their provider. At 1-month follow-up, there were 3 additional patients who reported a COVID-19 infection and 18 patients who received an additional COVID-19 vaccination. The baseline EORTC QLQ-C30 median Global Health Status/QOL score was 66.7 (mean=64.4, range: 8.3 - 100, n=196). This overall global QOL score was not significantly different between those who did vs. did not have a history of COVID-19 infection (mean [SD]: 63.7 [19.3] vs. 65.8 [17.6]; p=0.57). In analyses adjusted for age, biological sex, and race/ethnicity group, history of COVID-19 infection was not associated with HRQOL (odds ratio=0.93, 95% CI: 0.78 - 1.10; p=0.38). Data collection is ongoing and final study results will be reported at a later date.

Conclusion: COSMIC is a prospective, decentralized study within a site-based provider network conducted by the ASH Research Collaborative Multiple Myeloma Program that demonstrates the feasibility of using an innovative evidence generation strategy to drive rapid accrual of patients to address a rapidly evolving area of need. The COSMIC study also provides proof of concept that a real-world evidence generation network can play an important role in national pandemic preparedness and response. The COSMIC experience reinforces the ability to accrue diverse patient populations representing the demographic of myeloma patients in the US.

Usmani:Takeda: Consultancy, Research Funding; TeneoBio: Consultancy; Array Biopharma: Research Funding; Johnson & Johnson - Janssen: Consultancy, Research Funding; Genentech: Consultancy; Oncopeptides: Consultancy; Gilead: Research Funding; Abbvie: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Bristol-Myers Squibb - Celgene:: Consultancy, Research Funding; Pharmacyclics: Research Funding; Bristol-Myers Squibb - Celgene: Consultancy, Research Funding; Gracell: Consultancy; Pfizer: Consultancy; Amgen: Consultancy, Research Funding; SecuraBio: Consultancy; SkylineDX: Consultancy, Research Funding; SeaGen: Consultancy, Research Funding; Merck: Research Funding; GSK: Consultancy, Research Funding; EdoPharma: Consultancy; Sanofi: Consultancy, Research Funding. Wood:ASH Research Collaborative: Consultancy; Pfizer: Research Funding; Genetech: Research Funding; Koneksa Health: Consultancy, Current equity holder in publicly-traded company; Teledoc Health: Consultancy. Schroeder:Incyte: Honoraria; Kura Oncology: Honoraria; Advarra: Honoraria. Rosenberg:BMS: Consultancy; Kangpu Pharmaceuticals: Research Funding; Biomea: Research Funding; Pfizer: Consultancy; Sanofi: Membership on an entity's Board of Directors or advisory committees. Zonder:BMS (employment of spouse): Current Employment; Regeneron: Consultancy; BMS, Janssen, RLL: Research Funding. Rubinstein:Johnson & Johnson: Consultancy; Sanofi: Consultancy; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Other: Abemca; LAVA Therapeutics: Consultancy. D'Souza:Novartis: Research Funding; Caelum: Research Funding; Bristol Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Kedrion: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Research Funding; Prothena: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Regeneron: Research Funding; Takeda: Research Funding. Martin:GSK: Honoraria; Roche: Honoraria; BMS: Research Funding; Janssen: Research Funding; Sanofi: Research Funding; Pfizer: Honoraria; AMGEN: Research Funding. Chari:Abbvie, Adaptive, Amgen, Antengene, Bristol Myers Squibb, Forus, Genetech/Roche, Glaxo Smith Klein, Janssen, Karyopharm, Millenium/Takeda, Sanofi/Genzyme: Consultancy; Janssen: Research Funding. Vij:Sanofi, BMS, Takeda: Other, Patents & Royalties; Janssen, Pfizer, GSK, Regeneron, Karyopharm: Other, Patents & Royalties. Nooka:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Cellectar Biosciences: Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; K36 Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees; ONK Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sebia: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Aduro Biotech: Research Funding; Arch Oncology: Research Funding; Cellectis: Research Funding; Genentech: Research Funding; Adaptive Biotechnologies: Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Research Funding; Kite Pharma: Research Funding; Merck: Research Funding. Anderson:Window: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; C4 Therapeutics: Membership on an entity's Board of Directors or advisory committees; Dynamic Cell Therapies: Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy; AstraZeneca: Consultancy; Genentech: Consultancy; Amgen: Consultancy; Starton Therapeutics: Membership on an entity's Board of Directors or advisory committees. Neuberg:Madrigal Pharmaceutical: Current equity holder in publicly-traded company. Weiss:ModernaTX, Inc.: Current Employment, Current equity holder in private company, Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company, Ended employment in the past 24 months. Kumar:Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Research Funding; Novartis: Research Funding; Merck: Research Funding; Sanofi: Research Funding; KITE: Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; MedImmune/AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Research Funding; Oncopeptides: Other: Independent review committee participation; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding.