A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Phase 1
317
about 12 years
18+
13 sites in CA, GA, IN +8
What this study is about
This trial is testing a new drug called linvoseltamab when combined with other cancer treatments for people whose multiple myeloma has returned after previous treatment. The goal is to see if this combination is safe and effective, and to determine the best dose of linvoseltamab in these combinations.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Bortezomib
- 2.Take Carfilzomib
- 3.Take Cemiplimab
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
bortezomib, carfilzomib, cemiplimab, monoclonal antibody, daratumumab, isatuximab, lenalidomide (Immunomodulatory drug; affects immune system and cancer cells (exact mechanism unclear)), nirogacestat
injection (Injection), infusion, oral (Oral Capsule), oral (Oral Tablet)
Primary: Incidence of adverse events of special interest (AESIs), Incidence of pre-defined safety criteria or dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period, Incidence of serious adverse events (SAEs), Incidence of treatment-emergent adverse events (TEAEs), Severity of SAEs, Severity of TEAEs
Secondary: Duration of response (DOR) by IMWG criteria, Objective response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria, Overall Survival (OS), Progression-free survival (PFS) as measured by IMWG criteria
Oncology