This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
* This is a three-arm, non-randomized, multicenter, prospective study in adult patients with RRMM, who are administered Teclistamab (TECVAYLI™) or Talquetamab (TALVEY™), in the post-marketing setting. * Teclistamab (TECVAYLI™) is a humanized IgG-4 PAA bispecific antibody designed to target the CD3 receptor complex on T cells and BCMA on B-lineage cells. * Talquetamab (TALVEY™) is a humanized IgG-4 bispecific antibody designed to target the CD3 receptor complex on T cells and GPRC5D-expressing multiple myeloma (MM) cells This study will investigate the use of prophylactic tocilizumab or prophylactic dexamethasone to reduce the incidence and severity of CRS associated with teclistamab or talquetamab administration, to enable administration of the step-up dosing regimen of teclistamab or talquetamab in an outpatient setting.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.
Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks
Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.
Arizona Oncology Associates
Tucson, Arizona, United States
RECRUITINGIncidence of CRS of any grade during the first two cycles
Evaluate the overall incidence of CRS in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of recurrent CRS of any grade
Evaluate the incidence of recurrent CRS either after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of CRS of any grade
Evaluate the incidence of CRS after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of recurrent CRS of any grade
Evaluate the incidence of recurrent CRS after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
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Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.
Colorado Blood Cancer Institute
Denver, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
RECRUITINGMedical Oncology Hematology Consultants
Newark, Delaware, United States
RECRUITINGFlorida Cancer Specialists
Lake Mary, Florida, United States
RECRUITINGMaryland Oncology Hematology
Columbia, Maryland, United States
RECRUITINGMinnesota Oncology Hematology
Minneapolis, Minnesota, United States
RECRUITINGVirginia Oncology Associates
Elizabeth City, North Carolina, United States
RECRUITINGOncology Hematology Care
Cincinnati, Ohio, United States
RECRUITINGOncology Associates of Oregon
Eugene, Oregon, United States
RECRUITING...and 7 more locations
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of Recurrent Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles and throughout the study after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Recurrent Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles and throughout the study after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥3 and any grade infections
Evaluate the risk of Grade ≥3 and any grade infections throughout the study based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of All grade and Grade ≥3 neurotoxicity
Evaluate neurotoxicity in the setting of prophylactic tocilizumab or prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of All grade and Grade ≥3 ICANS
Evaluate neurotoxicity including ICANS in the setting of prophylactic tocilizumab or prophylactic oral dexamethasone based on the American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS (Grade 1 to 4 with grade 4 representing a worse outcome)
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Incidence of All grade neutropenia and Grade ≥3 neutropenia
Evaluate treatment-emergent neutropenia in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of all grade febrile neutropenia and Grade ≥3 febrile neutropenia
Evaluate treatment-emergent febrile neutropenia in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Total length of each hospital stay
Evaluate the length of each hospital stay in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Number of hospitalizations per participant
Evaluate the number of hospitalizations per participant, in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Healthcare resource utilization in the outpatient setting
Monitor the utilization of healthcare resources in the outpatient setting to mitigate the AEs associated with CRS/ICANS in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Overall response rate (ORR)
Overall response rate (ORR) will be defined as the proportion of participants who achieve a PR or better response according to the IMWG response criteria
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to initial response (TTR)
Time to initial response (TTR) will be defined as the time between the date of the first dose of teclistamab or talquetamab and the first efficacy evaluation that the participants have met all criteria for PR or better response according to the IMWG response criteria
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to best response (TTBR)
Time to best response (TTBR) will be defined as the time between the date of the first dose of teclistamab or talquetamab and the first efficacy evaluation that the participants have the best response according to the IMWG response criteria
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Duration of response (DOR)
Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG response criteria
Time frame: Day 1 of every 2 cycles from Cycle 1 Day 1 and up to approximately 12 months of teclistamab treatment or 6 months for talquetamab. (each cycle is 28 days)
Time to next treatment (TTNT)
Time to next treatment (TTNT) is defined as the time from the date of the first dose of teclistamab or talquetamab to the date of next treatment, or death due to any cause, whichever occurs first.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of the first dose of teclistamab or talquetamab to the date of death, due to any cause.
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of the first dose of teclistamab or talquetamab, to the date of first documented disease progression, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first.
Time frame: Day 1 of every 2 cycles From Cycle 1 Day 1 and up to approximately 12 months of teclistamab or 6 months for talquetamab treatment. (each cycle is 28 days)_
Timing of each hospital stay
Evaluate the timing of each hospital stay in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants who have had a change in health-related quality of life parameters, from baseline to end of treatment
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using EORTC-QLQ and Epstein taste scale
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants with oral toxicities
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using Epstein taste scale, PRO-CTCAE, STTA and SXI
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of patients with overall side effects
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using PGI-S and EORTC Q168/EORTC-IL46
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment
Talquetamab Arm only: Duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment