Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Summary
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
Detailed description
* 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.
Arms & interventions
- DrugTeclistamab
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.
- DrugTalquetamab
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
- DrugTocilizumab
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.
- DrugOral Dexamethasone
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.
Outcome measures
Primary
Incidence 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)
Secondary
Incidence of recurrent CRS of any grade
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
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of recurrent CRS of any grade
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥2 CRS
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
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
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Recurrent Grade ≥2 CRS
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥3 and any grade infections
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of All grade and Grade ≥3 neurotoxicity
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
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
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
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Total length of each hospital stay
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Number of hospitalizations per participant
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Healthcare resource utilization in the outpatient setting
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)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to initial response (TTR)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to best response (TTBR)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Duration of response (DOR)
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 frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Overall survival (OS)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Progression-free survival (PFS)
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
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
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants with oral toxicities
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of patients with overall side effects
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: 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
Time frame: Up 6 to months for talquetamab treatment
Talquetamab Arm only: Duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment
Eligibility criteria
Study locations (17)
Arizona Oncology Associates
Tucson, Arizona, 85711
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Medical Oncology Hematology Consultants
Newark, Delaware, 19713
Florida Cancer Specialists
Lake Mary, Florida, 32746
Maryland Oncology Hematology
Columbia, Maryland, 21044
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
Virginia Oncology Associates
Elizabeth City, North Carolina, 27909
Oncology Hematology Care
Cincinnati, Ohio, 45242
Oncology Associates of Oregon
Eugene, Oregon, 97401
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee, 37232
Texas Oncology
Austin, Texas, 78705
Texas Oncology - San Antonio
San Antonio, Texas, 78240
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Blue Ridge Cancer Center
Roanoke, Virginia, 24014