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Talquetamab/Teclistamab + PD-1 Inhibitor for Multiple Myeloma (TRIMM-3 Trial)
TRIMM-3 Trial Summary
This trial is testing a new cancer treatment combining a PD-1 inhibitor with either talquetamab or teclistamab. The goal is to find the safest dose of the PD-1 inhibitor to use in combination with either talquetamab or teclistamab, and to learn more about the side effects of this new treatment.
TRIMM-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRIMM-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRIMM-3 Trial Design
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Who is running the clinical trial?
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- I have previously received PD-1 inhibitors or had a stem or organ transplant.My condition has returned or didn't respond to treatment, and I can't use standard therapies.My multiple myeloma may be affecting my brain or spinal cord.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment in the last 3 weeks, including specific therapies in shorter time frames.My cancer can be measured by blood or urine tests.I have taken a high dose of steroids equivalent to 140 mg of prednisone or more in the last two weeks.I have a specific blood disorder such as plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis.My multiple myeloma diagnosis follows international guidelines.I have not received a live vaccine in the last 4 weeks.Side effects from my previous cancer treatment are mild or gone, except for hair loss or mild nerve pain.
- Group 1: Part 2: Dose Expansion
- Group 2: Part 1: Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are researchers currently seeking volunteers for this trial?
"Clinicaltrials.gov affirms that this experiment is actively seeking participants, having been initially posted on May 25th 2022 and last amended on December 1st 2022."
What are the fundamental goals of this trial?
"This clinical trial aims to measure the amount of adverse events (AEs) by severity with a two-year and five month timeframe. Secondary objectives include analysing the number of participants who have developed anti-teclistamab antibodies, time taken for response to treatment and serum concentrations of PD-1 inhibitor through validated immunoassay methods."
Could you explain what risks are associated with PD-1 Inhibitor therapy?
"The PD-1 Inhibitor's safety rating was judged to be 1 due to the limited data available for efficacy and safety from its phase 1 clinical trial."
How many healthcare establishments are administering this experiment?
"Participants for this trial can be found at Memorial Sloan Kettering Cancer Center, Colorado Blood Cancer Institute, and Wake Forest Baptist Medical Center. There are 3 additional enrolment sites located across the nation."
What is the current capacity of participants in this trial?
"Janssen Research & Development, LLC are the primary sponsors of this clinical trial and they need a total of 152 qualified participants to carry out their research. Major medicenter taking part in the study include Memorial Sloan Kettering Cancer Center (New york) and Colorado Blood Cancer Institute (Denver)."
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