A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma (NCT07105059) | Clinical Trial Compass
RecruitingPhase 1
A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma
United States18 participantsStarted 2025-08-08
Plain-language summary
The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).
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
. Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.
. Patients need to have measurable disease defined by one or more of the following:
. Serum myeloma (M)-protein greater than or equal to 0.5 g/dL (5 g/L).
. Urine M-protein greater or equal to 200 mg/24 h.
. Involved light chain (either kappa or lambda) \>10 mg/dL with an abnormal kappa: lambda ratio
. Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.
. A bone marrow biopsy demonstrating \>30% infiltration of clonal plasma cells.
. Patients who have received prior BCMA-directed therapy \> 90 days prior including antibody drug conjugates or chimeric antigen receptor T-cell \[CAR T\] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.
Exclusion criteria
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
Number of Participants With Dose Limiting Toxicity Assessed by CTCAE v5.0
. Prior treatment with a BCMA targeted bispecific antibody
. Prior treatment with mezigdomide
. Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
. Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.
. Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited \[i.e., ≤ 25% of bone marrow in field\] radiation therapy during this period).
. Live, attenuated vaccine or investigational vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed
. Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.
. Patients who received CAR T therapy within 90 days prior to study enrollment