Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (NCT05972135) | Clinical Trial Compass
RecruitingPhase 2
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
United States100 participantsStarted 2023-10-23
Plain-language summary
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent
* Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).
* Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.
* Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody.
* Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1.
Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.
* Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
* Serum M-protein level ≥0.5 g/dL; or
* Urine M-protein level ≥200 mg/24 hours; or
* Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
* For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).
* Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
* No detectable viral load (i.e., \<50 copies/mL) at screening
* CD4+ count \>300 cells/mm3 at screening
* No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
* Receivin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of CRS of any grade during the first two cycles
Timeframe: 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)