Introduction: Safe outpatient delivery of B-cell maturation antigen-targeting bispecific antibodies (BCMA-BsAbs) in multiple myeloma (MM) is challenging, particularly during step-up dosing (SUD). Standardized guidance for European community practice is limited. Methods: A modified Delphi methodology panel sought expert consensus on safe, effective outpatient SUD and transition of care from academic to community centers for patients receiving BCMA-BsAbs. A steering committee of 10 European specialists in MM and BCMA-BsAb delivery generated statements based on literature review and clinical experience. Statements were tested in three rounds with a Delphi panel of 53 clinicians (hematologists, nurses, pharmacists) across France, Germany, Italy, Portugal, Spain, and the United Kingdom. Consensus was defined as ≥ 75% agreement. Results: Consensus was achieved for 84 statements. Key recommendations included: (1) patient stability before community center transition (afebrile ≥ 24 h, ASTCT Grade 0 toxicity, stable organ function); (2) community center requirements (training in cytokine release syndrome/immune effector cell-associated neurotoxicity syndrome, urgent laboratory access, tocilizumab and corticosteroids on-site, 24/7 escalation protocols); and (3) infection management (baseline cytomegalovirus testing, immunoglobulin [Ig] monitoring, prophylaxis with intravenous/subcutaneous Ig for IgG < 400 mg/dL, antiviral/Pneumocystis jirovecii pneumonia prophylaxis). Outpatient SUD should be restricted to clinically stable patients with low tumor burden and reliable caregiver support and conducted only in centers with staff trained in BCMA-BsAb toxicity management and a clear escalation plan. Conclusion: This European Delphi consensus provides a structured framework for outpatient SUD and transition of BCMA-BsAb therapy in MM. Adopting these recommendations may improve safety and consistency and expand accessibility. Unlabelled: Trial Registration: The authors have confirmed clinical trial registration is not needed for this submission.
European Recommendations for Transitioning the Care of Patients With Multiple Myeloma Treated With B‐Cell Maturation Antigen Bispecific Antibodies From Academic Hospitals to Community‐Based Centers and for Outpatient Step‐Up Dosing
Gentile, Massimo;
2026-01-01
Abstract
Introduction: Safe outpatient delivery of B-cell maturation antigen-targeting bispecific antibodies (BCMA-BsAbs) in multiple myeloma (MM) is challenging, particularly during step-up dosing (SUD). Standardized guidance for European community practice is limited. Methods: A modified Delphi methodology panel sought expert consensus on safe, effective outpatient SUD and transition of care from academic to community centers for patients receiving BCMA-BsAbs. A steering committee of 10 European specialists in MM and BCMA-BsAb delivery generated statements based on literature review and clinical experience. Statements were tested in three rounds with a Delphi panel of 53 clinicians (hematologists, nurses, pharmacists) across France, Germany, Italy, Portugal, Spain, and the United Kingdom. Consensus was defined as ≥ 75% agreement. Results: Consensus was achieved for 84 statements. Key recommendations included: (1) patient stability before community center transition (afebrile ≥ 24 h, ASTCT Grade 0 toxicity, stable organ function); (2) community center requirements (training in cytokine release syndrome/immune effector cell-associated neurotoxicity syndrome, urgent laboratory access, tocilizumab and corticosteroids on-site, 24/7 escalation protocols); and (3) infection management (baseline cytomegalovirus testing, immunoglobulin [Ig] monitoring, prophylaxis with intravenous/subcutaneous Ig for IgG < 400 mg/dL, antiviral/Pneumocystis jirovecii pneumonia prophylaxis). Outpatient SUD should be restricted to clinically stable patients with low tumor burden and reliable caregiver support and conducted only in centers with staff trained in BCMA-BsAb toxicity management and a clear escalation plan. Conclusion: This European Delphi consensus provides a structured framework for outpatient SUD and transition of BCMA-BsAb therapy in MM. Adopting these recommendations may improve safety and consistency and expand accessibility. Unlabelled: Trial Registration: The authors have confirmed clinical trial registration is not needed for this submission.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
