This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
This trial is currently open and accepting patients.
This is a two-arm, non-randomized, multicenter, prospective study in adult patients with RRMM, who are administered Teclistamab (TECVAYLI™) or Talquetamab (TALVEY™), in the post-marketing setting.
This study will investigate the use of prophylactic tocilizumab to reduce the incidence and severity of CRS associated with teclistamab administration, to enable administration of the step-up dosing regimen of teclistamab in an outpatient setting.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Inclusion Criteria:
Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
Exclusion Criteria:
Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:
Presence of the following cardiac conditions:
History of antitumor therapy as follows, before the first dose of study drug:
History of stem cell transplant:
Phase 2
Enrollment: 75 patients (estimated)
View MoreDecember 09, 2024
Results: To date, 13 pts have been enrolled at 12 Sarah Cannon/US Oncology community sites. One pt developed diffuse bony lesions, weakness and pain due to rapidly progressing MM, did not complete the SUD regimen, and died on C1D40. Eleven pts have completed the SUD regimen per protocol and are included in the safety analysis. Median age was 70 (53-83) yrs; 5 pts were male; 6 pts were female, 1 Black, 6 White, 3 unknown, and 1 unreported. Pts had received a median of 4 (range, 4 to 6) prior lines of therapy. Hematologic adverse events (AEs) included neutropenia (1 pt gr 3, 3 pts gr 4) and lymphopenia (2 pts gr 1). No patients experienced febrile neutropenia. To date, no pts experienced CRS or ICANS or required hospitalization due to tec or Toci. A total of 7 infections, all gr 2, occurred in 4 pts. Seven pts developed IgG < 400 mg/dL, of whom 6 received IVIG replacement. Other AEs in >1 pt were fatigue, headache, and injection site reactions. Gr 2 hypotension (2 pts) was not attributed to CRS. Stopping criteria (gr > 3 CRS or NT/ICANS were not met. Seven pts are evaluable for clinical response (7/11); all 7 responded, achieving a complete response (CR) (n=1), very good partial response (VGPR) (n=5), or partial response (PR) (n=1). All 11 pts who have completed the SUD remain on study. Enrollment is ongoing.
Conclusion: Initial results from the OPTec study indicate that proToci may reduce the risk of CRS. None of the 11 subjects treated to date have experienced CRS or ICANS, and the safety profile is otherwise comparable to the pivotal MajesTEC-1 results. Enrollment is ongoing to determine if proToci may facilitate OP administration of the tec SUD schedule in an OP setting and increase patient accessibility in community centers. Additional data and follow-up in more pts, including PK data in the first 10 pts in addition to updated infection, IVIG use, and response data will be presented at ASH. The protocol is being amended to add a cohort of Talquetamab to determine if proToci can reduce CRS and facilitate OP SUDs across bispecific antibodies.
View all clinical trial locations sorted by state.
Denver, CO
Newark, DE
We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.
(888) 828-2206If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.
You can explore trial locations from around the US and connect directly with a trial coordinator.
Find Nearby LocationsYou can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.
Still need help? Send us a message