A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Phase 1/2
132
about 12 years
18+
13 sites in CA, CO, KY +5
What this study is about
Researchers are testing a new drug called linvoseltamab in adults with recently diagnosed multiple myeloma who are not yet treated. The goal of this clinical trial is to determine if the drug is safe, well-tolerated, and effective at shrinking tumors in these patients. It will involve two phases: Phase 1 to assess safety and dosage, and Phase 2 to evaluate tumor shrinkage.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Linvoseltamab
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.
Primary: Incidence of Adverse Events of Special Interest (AESIs), Incidence of Dose-Limiting Toxicities (DLTs), Incidence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs
Secondary: DOR by risk levels, DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Duration Of Response (DOR) measured using the IMWG criteria, Incidence of TEAEs, ORR by risk levels, ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Objective Response Rate (ORR) measured using the IMWG criteria, Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Oncology