Round 0

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Instructions

This questionnaire is the first step of the Delphi consensus. The goal specifically is to gather your current perspective and experiences using chimeric antigen receptor T-cell (CAR-T) therapy and/or bispecific antibodies (BsAb) for treating relapsed-refractory multiple myeloma (RRMM) in adults in an outpatient setting. The questions focus on the hospital set up required for administration of CAR-T and BsAb in an outpatient setting, the ideal patient profile, as well as the product risk profile for outpatient administration. We also seek to understand your opinion on the risks and benefits of providing these treatments in an outpatient setting.

This questionnaire includes three main sections: an initial section to confirm your eligibility, followed by sections focused on BsAb and CAR-T therapies. Depending on your clinical experience, you may be asked to complete one or both of the latter sections. The questionnaire consists of up to 52 questions and is expected to take approximately one hour to complete. Please respond based on your professional opinion and experience.

Your valuable input in this round will serve as the foundation for developing the statements that we will seek your consensus on in the next round.

Confirmation of eligibility

1. Which of the following best describes your role?*

Physician

Nurse

Pharmacist

2. In which province or territory are you currently practicing?*

Alberta

British Colombia

Manitoba

New Brunswick

Newfoundland and Labrador

Nova Scotia

Ontario

Prince Edward Island

Quebec

Saskatchewan

Yukon

Northwest Territories

Nunavut

3. Please check the therapies and their respective care settings where you have experience with infusion and/or safety monitoring.*

BsAbs

CAR-T (Start at question 24)

BsAbs: In which setting(s) do you have experience with the step-up doses?*

Inpatient

Outpatient

CAR-T: In which setting(s) do you have experience with the infusion and safety monitoring?*

Inpatient

Outpatient

4. How many patients per year do you treat or manage in an outpatient setting with the following therapies? Please provide an approximate number for each.

a. BsAbs:*

Please enter a number greater than or equal to 1.

b. CAR-T:*

Please enter a number greater than or equal to 1.

5. Which of the following best represents the main centre in which you conduct clinical practice?*

Academic/Teaching Hospital (affiliated with a medical school or university)

Community Hospital

Bispecific antibody questionnaire

Section 1: Institutional Requirements

1. Does your institution have established protocols or guidelines for outpatient administration of BsAb step-up doses (e.g., eligibility, monitoring, logistics etc.)?*

Yes

Please describe briefly:*

Please describe any alternatives currently used:*

2. Please list key elements of an effective escalation pathway that supports timely and streamlined inpatient admission of patients receiving BsAb step-up doses outpatient.*

3. Is it essential to have a core multidisciplinary team overseeing both administration and safety monitoring when the step-up doses are delivered in an outpatient setting?*

Yes

Please list all healthcare providers you believe should be included in this core team (e.g., physicians, specialists, nurses, pharmacists).

For each healthcare provider, please specify the step they are involved (administration and/or safety monitoring) by marking an X in the appropriate column. Please add a row for each healthcare provider by clicking the ‘+’ on the right.

Healthcare provider

Administration (check if applicable)

Safety Monitoring (check if applicable)

Please explain briefly*

4. Should patients have 24/7 access to a care team (remotely or onsite) when receiving the step-up doses in an outpatient setting?*

Yes

Please address the following:

a. What duration of 24/7 access (e.g., number of days post-injection) is necessary?*

b. Should 24/7 access be required for all patients, or only for those in specific risk categories? If the latter, please specify which risk categories.*

Please specify the minimal level of access you believe is necessary to ensure patient safety:*

5. Do you have access to tools, such as those that support patient scheduling, staffing, or capacity forecasting, for optimal delivery of outpatient BsAbs?*

Yes

Please indicate which tools are currently implemented at your institution:*

Please describe what tools would be valuable to have:*

6. Should access to reserved beds for inpatient admission be a minimum requirement to support outpatient BsAbs?*

Yes

Please address the following:

a. Where should the reserved beds be located (e.g., observation unit, emergency department)?*

b. The optimal duration (i.e., days, weeks) for which reserved beds should be made available.*

c. What do you consider an optimal ratio of reserved beds to patients receiving or projected to receive BsAb step-up doses?*

Please explain briefly:*

7. For how long should patients be monitored at the outpatient setting on the day of administration following each step-up dose?*

8. What is the recommended frequency of onsite safety follow-up at the outpatient center after each step-up dose?*

9. What are the clinical parameters that should be evaluated as part of remote monitoring?*

a. What tools can be used or are currently in use for remote monitoring at your institution?*

10. Which of the following medications, and the minimum number of doses, should be available in clinic when BsAbs step-up doses are administered in the outpatient setting? (Please check all that apply)*

Tocilizumab

Dexamethasone

Others

Tocilizumab minimum number of doses:*

Dexamethasone minimum number of doses:*

If others, please specify:*

11. Should the availability of medications for treatment of serious adverse events (AEs) be considered a minimum institutional requirement for administering the step-up doses in an outpatient setting?*

Yes

Please select which drug should be available and indicate number of doses per patient: (please check all that apply)*

Tocilizumab

Dexamethasone

Others

Tocilizumab number of doses:*

Dexamethasone number of doses:*

Please specify the drug(s) and the number of doses:*

Please explain briefly:*

12. Under what circumstances, if any, could dexamethasone be used as an alternative to tocilizumab for the management of CRS-related AEs in the outpatient setting? Please specify what clinical or logistical factors should be taken into consideration.

AEs = Adverse events; CRS = cytokine release syndrome*

AEs = Adverse events; CRS = cytokine release syndrome

13. What minimal support should institutions provide to patients and caregivers to ensure safe and effective delivery of outpatient BsAbs?*

14. Please list what you consider to be the most significant institutional benefits of providing BsAbs step-up doses outpatient.

15. Please list what you consider are the most significant institutional hurdles of providing BsAbs step-up doses outpatient.

a. What strategies can institutions implement to address these hurdles?*

Section 2: Patient Eligibility Criteria

16. What are the clinical criteria that make a patient eligible for receiving BsAbs step-up doses in an outpatient setting (e.g., age, performance status, comorbidities)?

17. What are the non-clinical criteria that make a patient suitable for receiving BsAbs step-up doses in an outpatient setting (e.g., access to caregiver, proximity to centre etc.)?

18. What are the most significant benefits for patients receiving BsAbs step-up doses outpatient?

19. What are the most significant risks to patients receiving BsAbs in outpatient setting and what strategies can be implemented to mitigate these risks?

Section 3: Product Risk Profile

20. Is the product safety profile of BsAbs important in determining suitability for outpatient treatment?*

Yes

Please explain briefly:*

21. Are the timing and predictability of AEs onset important in determining product suitability for outpatient treatment?*

Yes

Please explain briefly:*

22. Please provide information on outpatient and inpatient management of AEs.

a. Indicate the AE types and the maximum acceptable severity/grade for outpatient management (e.g. CRS up to Grade 1, ICANs up to Grade 2, infections):

Please add a row for each AE by clicking the ‘+’ on the right.

ICANS = immune effector cell-associated neurotoxicity syndrome*

Adverse Event

Severity grade

ICANS = immune effector cell-associated neurotoxicity syndrome

b. Indicate the AEs and severity levels you believe require inpatient care:

Please add a row for each AE by clicking the ‘+’ on the right.

Adverse event

Severity grade

23. Beyond AEs and toxicity, what product characteristics do you consider most important when assessing suitability for outpatient administration?*

CAR-T Questionnaire

Section 4. Institutional Requirements

24. Does your institution have established protocols or guidelines for the delivery of CAR-T cell therapy in an outpatient setting (e.g., eligibility, monitoring, logistics etc.)?*

Yes

Please describe briefly:*

Please describe any alternatives currently used:*

25. Please list key elements of an effective escalation pathway that supports timely and streamlined inpatient admission of patients receiving CAR-T cell therapy outpatient, when needed.*

26. Is it essential to have a core multidisciplinary team overseeing both infusion and safety monitoring when CAR-T cell therapy is administered in an outpatient setting?*

Yes

Please list all healthcare providers you believe should be included in this core team (e.g., physicians, specialists, nurses, pharmacists).

Healthcare provider

Administration (check if applicable)

Safety Monitoring (check if applicable)

Please explain briefly:*

27. Should patients have 24/7 access to a care team (remotely or onsite) when receiving CAR-T cell therapy in an outpatient setting?*

Yes

Please address the following:

a. What duration of 24/7 access (e.g., number of days post-infusion) is necessary?*

b. Should 24/7 access be required for all patients, or only for those in specific risk categories? If the latter, please specify which risk categories.*

Please specify the minimal level of access you believe is necessary to ensure patient safety.*

28. Do you have access to tools, such as those that support patient scheduling, staffing, or capacity forecasting, for optimal delivery of CAR-T cell therapy outpatient?*

Yes

Please indicate which tools are currently implemented at your institution.*

Please describe what tools would be valuable to have.*

29. Should access to reserved beds for inpatient admission be a minimum requirement to support outpatient CAR-T cell therapy?*

Yes

Please address the following:

a. Where should the reserved beds be located (e.g., observation unit, nearby inpatient unit, emergency department)?*

b. The optimal duration (i.e., days, weeks) for which reserved beds should be made available.*

c. What do you consider an optimal ratio of reserved beds to patients receiving or projected to receive CAR-T therapy?*

Please explain briefly:*

30. For how long should patients be monitored at the outpatient setting on the day of infusion?*

31. What is the recommended frequency of onsite safety follow-up at the outpatient center post-infusion?*

32. What are the clinical parameters that should be evaluated as part of remote monitoring?*

a. What tools can be used or are currently in use for remote monitoring at your institution?*

33. Is there a role for pre-emptive inpatient admission following outpatient delivery of CAR-T cell therapy?*

Yes

Please address the following:

a. Under what circumstances should pre-emptive inpatient admission be considered?*

b. What factors determine the optimal timing for pre-emptive admission?*

Please explain briefly:*

34. Which of the following medications, and the minimum number of doses, should be available in clinic when CAR-T cell therapy is administered in the outpatient setting? (Please check all that apply)*

Tocilizumab

Dexamethasone

Others

Tocilizumab minimum number of doses:*

Dexamethasone minimum number of doses:*

If others, please specify:*

35. Should the availability of medications for treatment of serious adverse events (AEs) be considered a minimum institutional requirement for administering CAR-T cell therapy in an outpatient setting?*

Yes

Please select which drug should be available and indicate number of doses per patient: (Please check all that apply)*

Tocilizumab

Dexamethasone

Others

Tocilizumab number of doses:*

Dexamethasone number of doses:*

Please specify the drug(s) and the number of doses:*

Please explain briefly:*

36. Under what circumstances, if any, could dexamethasone be used as an alternative to tocilizumab for the management of CRS-related AEs when CAR-T cell therapy is administered in the outpatient setting? Please specify what clinical or logistical factors should be taken into consideration.

AEs = adverse events; CRS = cytokine release syndrome*

AEs = adverse events; CRS = cytokine release syndrome

37. What minimal support should institutions provide to patients and caregivers to ensure safe and effective delivery of outpatient CAR-T therapy?*

38. What are the most significant institutional benefits of providing CAR-T cell therapy outpatient?

39. What are the most significant institutional hurdles to providing CAR-T cell therapy outpatient?

a. What strategies can institutions implement to address these hurdles?*

Section 5. Patient Eligibility Criteria

40. What are the clinical criteria that make a patient eligible for receiving CAR-T cell therapy in an outpatient setting (e.g., age, performance status, comorbidities)?

41. What are the non-clinical criteria that make a patient suitable for receiving CAR-T cell therapy in an outpatient setting (e.g., access to caregiver, proximity to centre, etc.)?

42. What are the most significant benefits to patients receiving CAR-T cell therapy outpatient?

43. What are the most significant risks to patients receiving CAR-T cell therapy outpatient?

a. What strategies can be implemented to mitigate these risks?*

Section 6. Product Risk Profile

44. Is the product safety profile of CAR-T cell therapy important in determining suitability for outpatient treatment?*

Yes

Please explain briefly:*

45. Are the timing and predictability of AE onset important in determining product suitability for outpatient treatment?*

Yes

Please explain briefly:*

46. Please provide information on outpatient and inpatient management of AEs.

a. Indicate the AE types and the maximum acceptable severity/grade for outpatient management (e.g. CRS up to Grade 1, ICANs up to Grade 2, infections):

Please add a row for each AE by clicking the ‘+’ on the right.

ICANS = immune effector cell-associated neurotoxicity syndrome*

Adverse Event

Severity grade

ICANS = immune effector cell-associated neurotoxicity syndrome

b. Indicate the AEs and severity levels you believe require inpatient care:

Please add a row for each AE by clicking the ‘+’ on the right.

Adverse event

Severity grade

47. Beyond AEs and toxicity, what product characteristics do you consider most important when assessing suitability for outpatient administration of CAR-T cell therapy?*